Corteria Pharmaceuticals initiates Phase 2 trial in heart failure and Phase 1 trial in obesity with its first-in-class CRF2 agonists

• CRAFT-WHF Phase 2 trial of COR-1167 initiated in patients with worsening heart failure

• Phase 1 trial of COR-1389 ongoing in subjects with obesity

Corteria Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of transformative therapies for heart failure and obesity, today announces the clinical advancement of its two first-in-class corticotropin‑releasing factor receptor 2 (CRF2) agonists, COR‑1167 and COR‑1389.

CRAFT-WHF Phase 2 trial of COR-1167 in worsening heart failure

COR-1167 is a once‑daily, subcutaneous CRF2 peptide agonist being developed for the treatment of worsening heart failure (WHF). In a randomized, placebo‑controlled Phase 1 trial, COR‑1167 was generally safe and well tolerated in healthy volunteers and patients with chronic heart failure. A single dose administered to patients demonstrated clear CRF2 target engagement based on improvement in a variety of cardiac function parameters, with no adverse impact on blood pressure.

Following the positive Phase 1 trial results, Corteria has initiated the CRAFT-WHF Phase 2 randomized, double-blind, placebo-controlled trial in patients with WHF (NCT06815471/EU CT 2024-518951-52). It will enroll a targeted 300 patients to assess the safety and cardiorenal effects of three different doses of COR-1167 administered for one month. Topline results are expected by the end of 2026.

Phase 1 trial of COR-1389 in obesity

COR-1389 is a long-acting once-weekly subcutaneous CRF2 peptide agonist being developed for the treatment of obesity with associated heart failure and right-sided heart failure due to pulmonary hypertension (Group 2).

A Phase 1 randomized, placebo‑controlled, trial of COR-1389 is ongoing (EU CT 2024-514853-31). The single ascending dose (SAD) phase investigating the safety, tolerability and pharmacokinetics in healthy volunteers has been completed and a 12-week multiple ascending dose (MAD) phase is now underway to assess the safety and efficacy of COR-1389 in subjects with obesity, including the evaluation of its effects on weight and body composition by whole-body MRI. Topline results are expected in the second half of 2026.

In a mouse model of diet induced obesity (DIO), COR-1389 showed substantial metabolic benefits associated with an increase in energy expenditure. It drove weight loss comparable to GLP1 agonists, while reducing fat mass and increasing lean (muscle) mass. When co-administered with tirzepatide or semaglutide, COR-1389 demonstrated additive benefits on fat loss while preventing the lean mass loss observed with these agents.

COR-1389 has also shown cardiopulmonary benefits in animal models of right-sided heart failure, improving cardiopulmonary hemodynamics and reversing maladaptive right ventricular and pulmonary artery remodeling. A Phase 1b trial is being planned to evaluate acute hemodynamic responses in patients with group 2 pulmonary hypertension, with topline results expected in the second half of 2026.

“Advancing both COR‑1167 and COR‑1389 in the clinic underscores our commitment to delivering first‑in‑class CRF2‑targeted therapies for patients with limited treatment options,” said Philip Janiak, founder and CEO of Corteria Pharmaceuticals. “The robust preclinical data, together with the emerging clinical data, strengthen our confidence as we move into Phase 2 and expand our footprint in cardiometabolic diseases.”

About Worsening Heart Failure

Chronic heart failure afflicts more than 60 million people worldwide. It is characterized by periods of clinical stability being frequently interrupted by episodes of worsening symptoms and signs, defined as worsening heart failure (WHF). Episodes of WHF impact more than 20% of heart failure patients and are among the most common causes for hospitalization, accelerating the progression of disease and resulting in substantial risk of morbidity and mortality. Given the central role of congestion in WHF, loop diuretics are the standard of care treatment. However, while effective acutely, these do not improve rehospitalization rates or patient outcomes. Therefore, WHF remains a critically important unmet medical need that continues to have a major impact on quality of life and imposes a major economic burden on the global healthcare system.

About Obesity with Associated Heart Failure

Obesity impacts more than one billion people worldwide and is a causal factor in heart failure and other serious health complications such as Type 2 diabetes, obstructive sleep apnea and sarcopenia. Implementing diet and exercise regimens are the first line of treatment, but this approach is frequently inadequate and can be accompanied by metabolic readjustment resulting in eventual regain of excess weight. The most effective currently available drug therapies for weight loss are GLP-1 and GLP-1/GIP peptides, but in many cases these drugs are associated with side effects such as bloating, nausea, and vomiting, leading to challenges with adherence and maintenance of weight loss. These therapies also often result in substantial loss of muscle mass, which can negatively impact patient health. Therefore, obesity remains a global health crisis and novel therapies are urgently needed that target fat loss with preserved lean mass, while also directly ameliorating comorbidities such as obesity-associated heart failure, which affects an estimated 30 million people worldwide.

About Right-Sided Heart Failure

Right-sided heart failure (RHF) is typically caused by pulmonary hypertension (PH) often associated with left-sided heart disease and afflicts approximately 10 million people worldwide. It is a fatal disease with no approved therapies and involves the development of right ventricular dysfunction (RVD) that leads to a progressive deterioration in exercise capacity and quality of life, and ultimately to a high risk of cardiovascular mortality. Despite therapeutic advances for left-sided heart disease, there are no therapies which specifically aim at improving RVD. Pulmonary vasodilators such as endothelin receptor antagonists, PDE-5 inhibitors and prostacyclin analogs are approved for pulmonary arterial hypertension, another smaller subgroup of PH, but these drugs have not been shown to be effective in the more common form of PH resulting from left-sided heart disease (classified as Group 2). The standard of care remains limited to diuretics for relieving symptoms of congestion. Therefore, novel therapies are urgently needed for the treatment of RHF due to Group 2 PH.

About Corteria Pharmaceuticals

Corteria is a privately held, clinical-stage biopharmaceutical company developing first-in-class medicines for the treatment of heart failure and obesity. The company is advancing a daily CRF2 peptide agonist, COR-1167, for the sub-chronic treatment of worsening heart failure; a long-acting once-weekly CRF2 peptide agonist, COR-1389, for the chronic treatment of obesity-associated heart failure and right-sided heart failure; and an arginine vasopressin neutralizing monoclonal antibody, COR-2007, for the treatment of acute heart failure with hyponatremia and autosomal dominant polycystic kidney disease.
www.corteriapharma.com

Contact

Stéphane Durant des Aulnois, CFO
Corteria Pharmaceuticals
stephane.durant_des_aulnois@corteriapharma.com

Andrew Lloyd & Associates
Juliette Schmitt / Saffiyah Khalique
juliette@ala.associates / saffiyah@ala.associates
UK: +44 1273 952 481
US: +1 203 724 5950

First Patient Dosed in XyloCor Therapeutics’ Phase 2b EXACT-2 Trial Evaluating XC001 for the Treatment of Coronary Artery Disease

• XC001 is a novel investigational therapy that previously demonstrated compelling efficacy and safety results, with disease-modifying potential, in patients with refractory angina in the EXACT-1 Phase 1/2 trial.

• In the global EXACT-2 trial, XC001 is injected directly into the heart muscle in a catheterization-lab setting, using the novel Extroducer® Infusion Catheter System, thereby eliminating the need for surgical administration.

XyloCor Therapeutics, a clinical-stage biopharmaceutical company focused on developing novel therapies for cardiovascular disease, announced the first patient has been dosed in the Phase 2b EXACT-2 trial, designed to evaluate its gene therapy candidate XC001 (encoberminogene rezmadenovec) in individuals with coronary artery disease and refractory angina. XC001 is an adenoviral vector-based gene therapy encoding for vascular endothelial growth factor (VEGF), uniquely designed as a one-time catheter-based treatment to reduce cardiac ischemia by creating new blood vessels in the heart and thereby reducing episodes of chest pain and improving patient ability to perform everyday activities. This percutaneous administration approach, injecting directly into the heart muscle, allows XC001 to achieve higher gene expression levels locally in the heart while minimizing systemic vector circulation and associated side effects.

“Initiating the EXACT-2 trial is an important milestone as we continue to develop XC001 for the treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality of life,” said Albert Gianchetti, President and CEO of XyloCor. “Building on the positive results from EXACT-1, we are now focused on advancing the EXACT-2 trial to bring this potentially transformative treatment to patients as quickly as possible.”

EXACT-2 is a Phase 2b, multicenter, randomized, double-blind study in 100 patients with refractory angina to evaluate the safety and efficacy of a one-time gene therapy with XC001, delivered using the Extroducer® Infusion Catheter System, an endocardial delivery catheter designed to inject advanced therapies directly into the heart in a simple injection procedure in the cardiac catheterization lab. Additional information can be found here. The first patient was dosed by Timothy Henry, MD, at The Christ Hospital Health Network in Cincinnati, OH.

“After seeing the convincing results from the EXACT-1 trial, we were eager to participate in EXACT-2,” commented Dr. Timothy Henry, a cardiovascular interventionist and the Lindner Family Distinguished Chair in Clinical Research and Medical Director of The Carl and Edyth Lindner Center for Research at The Christ Hospital. “We believe that XC001 delivered through the Extroducer® Infusion Catheter System will maintain the accuracy of delivery of XC001 to the heart and improve the safety over the surgical administration approach used in EXACT-1.”

The XC001 Phase 1/2 EXACT-1 trial results supported the transformative, disease-modifying potential of XC001 to reduce cardiac ischemia, reduce anginal symptoms and improve the quality ‑of ‑life for cardiac patients who have no other treatment options. The results demonstrated the potential for XC001 to be safely administered and achieve durable clinical improvements, including increases in exercise duration, decrease in ischemic burden as measured by Positron Emission Tomography (PET) imaging and a reduction in angina frequency. Notably, 93% of patients in the trial entered with chest pain so severe that it markedly limited daily activities, whereas at six months 43% reported no chest pain with ordinary activities. XC001 was well tolerated in the patient population and there were no serious adverse events related to the study drug.

XyloCor is also initiating a second clinical trial this year – a double-blind Phase 2 trial of XC001 as an adjunctive treatment to coronary artery bypass graft surgery (CABG).

About XC001

XC001 is designed to reduce cardiac ischemia by creating new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one-time, local administration and delivery through an adenoviral vector. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About Extroducer® Infusion Catheter System

The Extroducer® Infusion Catheter System is a first-in-class endovascular delivery device which enables direct-to-tissue drug delivery. The Extroducer® addresses a significant unmet need in the field of novel therapies, enabling targeted delivery of a wide range of treatment modalities to otherwise hard to reach tumors and organs. Using standard fluoroscopy equipment and routine interventional radiology approaches, the Extroducer provides access to hard-to-reach tissues by safely penetrating the vessel wall and delivering payload directly to the target location, or inside the heart ventricle. Smartwise received U.S. Food and Drug Administration (FDA) clearance under 510(k) for the Extroducer® delivery catheter in June 2022. In 2024, XyloCor entered into a licensing agreement with SmartWise, a unit of SmartCella, to deliver XC001 via the Extroducer® Infusion Catheter System.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen, resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass gracing (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain.

About XyloCor

XyloCor Therapeutics, Inc. is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development for use in patients with coronary artery disease and refractory angina for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in the discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

About SmartCella

SmartCella, founded in 2014, is a global biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. SmartCella combines novel delivery platforms, such as the Extroducer® (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell therapies. For more information, visit www.smartcella.com.

Contacts

XyloCor Corporate and Investor Relations Contact:
A. Brian Davis, XyloCor Therapeutics
brian.davis@xylocor.com
610-541-2056

XyloCor Media Contact:
Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

Priothera Secures EUR1.7 million i-Nov Funding by Bpifrance for Rare Blood Cancer Clinical Program

Funding to support MOCART, a clinical programme evaluating mocravimod added to standard CAR-T cell therapy

Priothera, a late-stage biopharma company pioneering the development of mocravimod, a novel oral sphingosine 1 phosphate (S1P) receptor modulator, to treat hematologic malignancies, today announced that it has been awarded nearly EUR1.7 million in non-dilutive funding through the i-Nov innovation competition. Part of the France 2030 initiative, i-Nov is a flagship French government program operated by Bpifrance to support breakthrough innovation from high-potential French companies across strategic sectors. The funding will support Priothera's clinical programme to evaluate whether adding mocravimod to commercial CAR-T cell therapies could improve patient outcomes.

CAR-T cell therapies represent a novel and promising modality for the treatment of hematological malignancies. They have demonstrated the potential for remarkable clinical responses and durable disease control in patients with acute lymphoblastic leukemia (ALL), non-Hodgkin lymphoma and multiple myeloma. However, their use is still associated with significant challenges, as 40-60% of patients treated with CAR-T cells experience high-grade toxicities, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), a form of severe neurological toxicity.

Mocravimod is a novel, oral S1P receptor modulator with a unique dual mechanism of action that has the potential to enhance the effectiveness of CAR-T cell therapy by:

• Reducing the incidence and severity of CRS and ICANS, and

• Improving response rates and durability of treatment

"We are honoured to receive this i-Nov funding from Bpifrance, which underscores the innovation and therapeutic potential of mocravimod beyond allo-HCT," said Florent Gros, Co-Founder and CEO of Priothera. "With its unique immunomodulatory properties, mocravimod is well-positioned to become a key component in the next generation of cell therapy regimens. The MOCART trial represents an exciting expansion of our clinical development into CAR-T therapy, building on our deep expertise in allo-HCT and momentum from our ongoing global Phase 3 MO-TRANS trial in acute myeloid leukemia."

Priothera continues to advance mocravimod in the MO-TRANS global Phase 3 study for patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (allo-HCT). The company remains focused on unlocking the full therapeutic potential of S1P receptor modulation across multiple settings in blood cancers.

About mocravimod

Mocravimod (KRP203) is a synthetic S1P receptor modulator being developed for the adjunctive and maintenance treatment of AML to enhance the curative potential of allo-HCT. Mocravimod's dual mechanism of action preserves the graft-versus-leukemia (GvL) effect, critical for eliminating cancer cells while reducing the risk of graft-versus-host disease (GvHD), a major complication following allo-HCT. This novel treatment approach -- mocravimod being the only S1P receptor modulator in development to treat blood cancers -- tackles a high unmet medical need and aims to improve treatment outcomes and patients' quality of life.

About Priothera

Priothera is a late-stage biopharma company pioneering the development of mocravimod, a potential new standard of care in hematologic cancers, in addition to cellular therapies such as hematopoietic cell transplantation and CAR-T cell therapies. Mocravimod is being developed as an adjunctive and maintenance therapy for hematological malignancies requiring allogeneic hematopoietic cell transplant (allo-HCT), focusing initially on acute myeloid leukemia (AML). Mocravimod is currently the only treatment with the potential to reduce transplant side effects of graft-versus-host disease (GvHD) without compromising the graft's anticancer effect against leukemia (Graft-versus-Leukemia, or GvL), thereby enhancing the curative potential of allo-HCT.

Founded in 2020, Priothera operates in France, with headquarters in Dublin. The company is led by a highly experienced management team with deep expertise in hematology, oncology, immunology and cell-based therapies. Priothera is backed by leading international life sciences investors, including Fountain Healthcare Partners, abrdn, EarlyBird Venture Capital, BEI and Bpifrance Grand Est.

For more information please visit www.priothera.com or follow Priothera on LinkedIn www.linkedin.com/company/priothera/

Vivasure Medical Submits PMA Application for PerQseal® Elite and Secures Expanded Venous Indication in Europe

Regulatory progress underscores global momentum for PerQseal Elite in transforming large-bore vascular closure

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its PerQseal® Elite vascular closure system for arterial procedures. The submission builds upon the successful results of the PATCH study as well as positive clinical use in Europe, reinforcing the system’s potential safety and performance profile. In addition, the company received European CE mark approval for an expanded indication for PerQseal Elite covering large-bore venous closure. This follows its first CE mark approval in April 2025 for arterial procedures and positions PerQseal Elite as the first fully bioresorbable, sutureless solution in Europe for both arterial and venous access closure.

“With the increasing adoption of minimally invasive therapies in structural heart and electrophysiology procedures, managing large-bore access sites remains a critical consideration,” said Azeem Latib, M.D., section head and director of interventional cardiology and director of structural heart interventions at Montefiore Health System in New York City. “PerQseal Elite was designed to address the growing need with a novel, fully bioabsorbable approach and we look forward to further progress in the program.”

Leveraging Vivasure’s PerQseal technology, the PerQseal Elite vascular closure system is designed for fully absorbable, sutureless closure following percutaneous cardiovascular procedures. Currently, there are no fully bioresorbable devices available on the market for closure following large-bore procedures. Moreover, unlike other current devices, PerQseal Elite does not require any pre-procedure steps, further simplifying the process.

“We are proud to advance PerQseal Elite through these two key regulatory milestones as part of our commitment to delivering next-generation technologies for large-bore vascular closure,” said Andrew Glass, CEO of Vivasure Medical. “Achieving CE mark expansion for venous indications and submitting our PMA application are important steps toward making our fully absorbable, sutureless solution more broadly accessible, while continuing to build a strong foundation for global commercial growth.”

The PerQseal Elite vascular closure system is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques and returning the vessel to its natural state without leaving materials like collagen, metal implants, or sutures behind.

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology, and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

In 2023, Vivasure Medical received a €30 million strategic investment from Haemonetics Corporation (NYSE: HAE), in an agreement which includes an option to acquire Vivasure Medical upon completion of certain milestones. The company is also backed by Fountain Healthcare Partners, Orchestra BioMed Holdings Inc. (Nasdaq: OBIO), LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners, and Evonik Venture Capital. In addition, Vivasure Medical has received support from Enterprise Ireland and the European Investment Bank.

The PerQseal® and PerQseal® Elite are not available for sale in the United States.

Neurent Medical Announces 510(k) Clearance of its Next Generation NEUROMARK® System

Developed in Collaboration with Leading ENT Experts, the Enhanced NEUROMARK® System Reflects Meaningful Innovation and Delivers Real-Time Feedback to Improve Patient Care

Neurent Medical, a leader in pioneering non-surgical solutions for chronic sinonasal inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Next Generation NEUROMARK®  System, marking a major milestone in advancing care for patients suffering from Chronic Rhinitis. This latest advancement in the NEUROMARK platform delivers a new level of control, confirmation, and confidence for otolaryngologists.  

The new system is designed to optimize the treatment of posterior nasal nerves by providing real-time feedback, guiding proper electrode placement, and confirming successful treatment delivery. The flexible shaft and atraumatic leaflets conform to patient anatomy, enabling physicians to reach challenging areas in the nasal cavity while maximizing treatment coverage. The NEUROMARK System delivers impedance-controlled, low-power radiofrequency (RF) energy to disrupt the parasympathetic nerve signals, addressing key symptoms of Chronic Rhinitis such as persistent nasal congestion and rhinorrhea (runny nose).

"We have just completed a highly successful commercial validation phase, positioning the NEUROMARK system at the forefront of Chronic Rhinitis care," said Brian Shields, CEO of Neurent Medical. "During this phase, we have collaborated with leading General ENT and Rhinology specialists across both private practice and academic settings. Their insights were instrumental in shaping this next-generation system. I am incredibly proud of how their feedback translated into meaningful technological improvements. This milestone highlights our continued commitment to innovations that empowers ENTs to treat patients with greater confidence."

"I have worked closely with the Neurent Medical team from the beginning and continue to be impressed by their dedication to ENT surgeons and our patients." said Dr. Marc Dubin, Chief Medical Officer, ENT Specialty Partners. "The latest generation of the NEUROMARK System reflects this commitment, incorporating usability enhancements and real- time feedback capabilities to support precise treatment delivery."

This FDA clearance paves the way for broader U.S. availability of the NEUROMARK System as Neurent Medical continues its mission to redefine the standard of care for Chronic Rhinitis, affecting nearly 1 in 4 Americans1.

About Neurent Medical

Neurent Medical is pioneering innovative treatments for chronic inflammatory sinonasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. Its proprietary NEUROMARK® technology, with a unique design and advanced smart algorithmic control, allows physicians to precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate chronic rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland, with US HQ in Braintree, MA. For more information visit www.neuromark.com.

1. Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23-34

Priothera Strengthens Board with Appointment of Industry Veteran, Dr. Hans Menssen

Highly experienced clinical development executive joins Priothera Board as mocravimod progresses through global Phase 3 trial as adjunctive and maintenance treatment in AML patients undergoing allo-HCT

Priothera Ltd., a late-stage biopharma company pioneering the development of mocravimod, a novel oral sphingosine 1 phosphate (S1P) receptor modulator, to treat hematologic malignancies, today announced the appointment of Dr. Hans Menssen, MD, PhD, BBA, to its Board of Directors.

Dr. Menssen most recently served as Senior Global Program Clinical Head at Novartis Oncology, where he led clinical programs across acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), multiple myeloma, chronic myeloid leukemia (CML), myelofibrosis, acute and chronic GvHD, and B-cell malignancies, with a focus on registration-stage development. Over his career, in addition to Novartis, he has held senior roles at Bayer Schering Pharma and Philogen SpA, with a track record of supporting oncology innovation across modalities including small molecules, antibodies, and cell therapies.

"Hans brings deep strategic insight in hematology, clinical development, and regulatory science," said Florent Gros, Co-Founder and CEO of Priothera. "His experience across global drug development programs and his understanding of what it takes to bring innovative therapies to patients will make him a valuable voice on our Board as we progress the global Phase 3 MO-TRANS study of mocravimod in AML patients undergoing allo-HCT. We are very pleased to welcome him to the Board."

A board-certified hematologist and oncologist, Dr. Menssen also holds academic appointments at Charité -- University Medicine Berlin in his capacity as assistant professor (Priv-Doz. Dr. med), where he continues to teach and supervise medical research. He has contributed to numerous clinical and translational research efforts throughout his career. He earned his medical degree from the University of Cologne, completed postdoctoral research at the Wistar Institute at the University of Pennsylvania, and holds a Bachelor of Business Administration in health economics from GSBA Zurich in partnership with SUNY (State University of New York).

"I am very pleased to join Priothera's Board at such a key point in its evolution," said Dr. Hans Menssen. "Mocravimod represents a promising and differentiated approach to improving outcomes in AML patients undergoing allo-HCT, and I look forward to supporting the team in advancing this important program."

Priothera's Board of Directors is composed of:

• Dr. Manus Rogan (Chair) -- Managing Partner, Fountain Healthcare Partners

• Mr. Florent Gros - CEO

• Dr. Marten Steen -- Managing Partner, Healthcap Ventures

• Dr. Henry Skinner -- CEO, AMR Action Fund

• Mr. Lionel Carnot -- Partner, Earlybird Health

• Dr. Hans Menssen -- former Senior Global Program Clinical Head, Novartis Oncology

Priothera Appoints Dr. Jens Hasskarl as Chief Medical Officer to Drive Late-Stage Clinical Development of Mocravimod, a S1P Receptor Modulator for Acute Myeloid Leukemia (AML)

Dr. Hasskarl to lead global Phase 3 MO-TRANS study evaluating mocravimod as an adjunctive treatment to allo-HCT in AML

Priothera Ltd., a late-stage biopharma company pioneering the development of mocravimod, a novel oral sphingosine 1 phosphate (S1P) receptor modulator, to treat hematologic malignancies, today announced the appointment of Jens Hasskarl, MD, PhD, as Chief Medical Officer (CMO). Dr. Hasskarl will oversee the global Phase 3 clinical study MO-TRANS of mocravimod, which is being developed as an adjunctive treatment in acute myeloid leukemia (AML) to enhance the curative potential of allogeneic hematopoietic cell transplantation (allo-HCT).

Dr. Hasskarl brings over two decades of international leadership experience in clinical development, translational science and medical affairs across top-tier pharma, biotech and academic institutions. Most recently, he served as CMO at Advesya AG, where he led the strategic development of novel immunotherapies in haemato-oncology and autoimmunity. He previously held senior executive roles at Tigen Pharma, Celgene and Novartis, where he was instrumental in the development and global approval of multiple cellular therapies including Breyanzi®, Abecma® and Kymriah®.

"Jens’ deep expertise in hematology, cellular therapy and translational drug development, combined with his entrepreneurial mindset and proven track record in leading successful global clinical programs, make him the ideal fit," said Florent Gros, Co-Founder and CEO of Priothera. "His insight and leadership will be critical as we prepare for the final phase of clinical execution and regulatory engagement for mocravimod. We would like to thank Dr. Elisabeth Kueenburg, Priothera’s former CMO, for her contributions and wish her every success in her future endeavors."

“I am thrilled to join Priothera during such an exciting phase,” said Dr. Hasskarl, CMO of Priothera. “The company’s science-driven approach and commitment to improving outcomes for patients with AML aligns perfectly with my focus on advancing innovation in hematology. I look forward to working closely with the team to bring this promising therapy to patients worldwide.”

Dr. Hasskarl holds an MD and PhD from Heidelberg University and the German Cancer Research Center. He completed a postdoctoral fellowship at Harvard Medical School and holds a diploma in Health Economics. He is a board-certified Internist with a specialty in hematology and oncology and continues to lecture at Freiburg Medical School in Germany.

About mocravimod

Mocravimod (KRP203) is a synthetic S1P receptor modulator being developed for the adjunctive treatment of AML to enhance the curative potential of allo-HCT. Mocravimod’s dual mechanism of action preserves the graft-versus-leukemia (GvL) effect, critical for eliminating cancer cells while reducing the risk of graft-versus-host disease (GvHD), a major complication following allo-HCT. This novel treatment approach – mocravimod being the only S1P receptor modulator in development to treat blood cancers – tackles a high unmet medical need and aims to improve patients’ quality of life.

About Priothera

Priothera is a late-stage biopharma company pioneering the development of mocravimod, a potential new standard of care in hematologic cancers, in combination with cellular therapies such as hematopoietic cell transplantation and CAR-T cell therapies. Mocravimod is being developed as an adjunctive and maintenance therapy for hematological malignancies, focusing initially on acute myeloid leukemia (AML), in combination with allogeneic hematopoietic cell transplant (allo-HCT). Mocravimod is currently the only treatment with the potential to reduce transplant side effects of graft-versus-host disease (GvHD) without compromising the graft’s anticancer effect against leukemia (Graft-versus-Leukemia, or GvL), thereby enhancing the curative potential of allo-HCT.

Founded in 2020, Priothera operates in France, with headquarters in Dublin. The company is led by a highly experienced management team with deep expertise in hematology, oncology, immunology and cell-based therapies. Priothera is backed by leading international life sciences investors, including Fountain Healthcare Partners, abrdn, EarlyBird Venture Capital, BEI and Bpifrance Grand Est.

For more information please visit www.priothera.com or follow Priothera on LinkedIn www.linkedin.com/company/priothera/

Contacts:

Florent Gros, CEO
E: info@priothera.com

Mainstay Medical Announces Exclusive Coverage of ReActiv8® by Anthem Blue Cross/Blue Shield

Mainstay Medical Holdings plc today announced that Anthem Blue Cross and Blue Shield (“Anthem”) has established favorable coverage for the company’s ReActiv8 Restorative NeurostimulationTM therapy for the treatment of intractable chronic low back pain. ReActiv8 is the only therapy considered medically necessary by the policy when the conditions for coverage are met. The coverage went into effect on April 16, 2025, and expands access to the procedure, when clinically appropriate, to Anthem’s policyholders.

“We have been on a 17-year mission to prove the value of ReActiv8 through careful and thorough research,” said Jason Hannon, CEO of Mainstay Medical. “We have made a commitment to developing a large body of robust clinical and real-world evidence proving the efficacy and safety of the therapy in an indication where patients are desperately seeking durable solutions. We are pleased to see a leading payer like Anthem recognize the evidence we have built, and we look forward to discussing our data with other major health plans with the goal of securing further coverage for ReActiv8. Our evidence has been generated by scores of clinical investigators around the world who care for chronic back pain patients. We are extremely grateful for the work these physicians continue to do.”

Under its policy, Anthem considers ReActiv8 to be medically necessary for the treatment of chronic low back pain when a number of clinical criteria are met. These include a diagnosis of lumbar multifidus muscle dysfunction and patient selection criteria consistent with FDA approval guidelines and Mainstay’s clinical trial protocols.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction, which may be evidenced by imaging or physiological testing. Candidates for ReActiv8 are patients with multifidus muscle dysfunction who have failed other forms of therapy (including pain medication and physical therapy) and are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative NeurostimulationTM system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

Vivasure Medical Receives CE Mark Approval in Europe for PerQseal Elite Vascular Closure System

First fully absorbable, sutureless closure system designed for large-bore procedures aims to improve procedural efficiency and patient outcomes in structural heart interventions

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced European CE mark approval of the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device. The company plans to launch the product in select European markets this summer.

Leveraging Vivasure’s PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore closure following percutaneous cardiovascular procedures such as transcatheter aortic valve replacement (TAVR) and Endovascular Aortic Repair (EVAR). Currently, there are no fully bioresorbable devices available for closure following large-bore procedures. Moreover, unlike other current devices, PerQseal Elite does not require any pre-procedure step, further simplifying the procedure.

“Vascular closure remains a challenge for the growing cardiovascular procedures that require large bore access. The introduction of PerQseal Elite is an exciting advancement for large-bore cardiovascular procedures,” said Dr. Mohamed Abdel-Wahab, Professor of Interventional Cardiology and Head of Structural Heart Disease Department at the Heart Center in Leipzig, Germany. “Having a fully absorbable, sutureless closure option simplifies the procedure and has the potential to reduce complications associated with traditional closure methods. We look forward to utilizing this technology to treat our patients.”

“Securing CE Mark approval for PerQseal Elite marks a major milestone for Vivasure and for patients undergoing complex structural heart procedures,” said Andrew Glass, CEO of Vivasure Medical. “PerQseal Elite represents a significant advancement in procedural efficiency and patient care. We’re proud to bring this innovative technology to clinicians across Europe.”

The PerQseal Elite vascular closure system is placed from inside the vessel, making deployment simpler and more controlled than conventional closure techniques and returning the vessel to its natural state without leaving materials like collagen, metal implants or sutures behind.

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

In 2023, Vivasure Medical received a €30 million strategic investment from Haemonetics Corporation (NYSE: HAE), in an agreement which includes an option to acquire Vivasure Medical upon completion of certain milestones. The company is also backed by Fountain Healthcare Partners, Orchestra BioMed Holdings Inc. (Nasdaq: OBIO), LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital. In addition, Vivasure Medical has received support from Enterprise Ireland and the European Investment Bank.

The PerQseal® and PerQseal® Elite are not available for sale in the United States.

Neuromod Closes €10m Financing to Accelerate Commercialisation

• Financing led by existing investors Fountain Healthcare Partners and Panakès Partners

• Neuromod will use funds to accelerate commercialisation in the USA and Europe.

Neuromod Devices Ltd. (Neuromod), an Irish medical device company specialising in tinnitus, has successfully closed a €10 million equity financing to expand the availability of its tinnitus treatment device, Lenire.

Oversubscribed Financing to Drive Commercialisation

Neuromod has raised €10 million of equity in an expansion of its Series B fundraisings. The financing was oversubscribed and was led by existing investors Fountain Healthcare Partners and Panakès Partners, backing Neuromod’s mission to advance tinnitus care for patients globally.

Neuromod has been making Lenire available through audiology and ENT practices throughout the USA and Europe. Proceeds from the financing will be used to meet demand for Lenire through sustainable commercial expansion in the USA and Europe and expand on existing opportunities in the US Department of Veteran Affairs (USVA).

Following FDA approval in March 2023, more than 100 clinics throughout the USA now treat tinnitus patients with Lenire. Availability of Lenire has also expanded in Europe with clinics in 14 countries now using the device. In the last 6 months, the number of clinics in the UK trained to use Lenire has doubled, and it is available to patients in Sweden for the first time.

In June 2024, Neuromod was awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making Lenire a treatment option for the 2.9 million US Veterans living with tinnitus [v] through the USVA.

35 USVA facilities have been trained to provide treatment with Lenire with more scheduled for training in 2025.

Real-World Evidence – Substantial Momentum

Positive results for tinnitus patients treated with Lenire in real-world settings at independent USA-based clinics have been compiled with a base of over 1,500 patients that continues to grow. In what will be the first of a series of planned real-world evidence publications, results from Alaska Hearing & Tinnitus Center showed that 91.5% of 220 patients reported clinically significant improvement in their tinnitus [vi]. This data is consistent with, and in many instances outperforms, data from Lenire’s large-scale clinical trials.

These results followed the publication of Lenire’s pivotal controlled clinical trial results, which led to US FDA approval and featured as the cover-story in peer-reviewed journal, Nature Communications [iv]. This article is in the 99th percentile of more than 250,000 tracked Nature articles.

Neuromod Closes €10m Financing Comments

Commenting on the news, Dr. Ross O’Neill PhD, Founder & CEO of Neuromod said “We are delighted to announce an oversubscribed financing at a pivotal time when we are driving forward with our mission of making Neuromod the category creator for tinnitus globally.”

“Tinnitus is the largest unmet need in hearing healthcare globally and is the number one service-connected disability among US veterans and military personnel. I am proud of the progress Neuromod is making to deliver our market-surpassing treatment to as many tinnitus patients as possible while enabling care providers’ expertise to be commercially rewarded. I am also grateful for the continued support of our investors who share our vision of advancing tinnitus care globally.” Dr. O’Neill continued.

Dr. Manus Rogan, Chairman of Neuromod and Managing Partner of Fountain Healthcare Partners commented, “Recent results from tinnitus patients using Lenire in the real-world show that it represents a new standard of care for tinnitus. The successful closing of this financing ensures more patients will get access to this standard of care as quickly as possible.”

Alessio Beverina, Managing Partner of Panakès Partners said, “Panakès is pleased with the progress of Neuromod since our investment, with significant clinical trial, FDA approval, real-world evidence, and commercial success in both Europe and the USA; and it is proud to continue supporting Neuromod’s work to bring a new standard of care to a historically underserved patient population.”

Emily E. McMahan, Owner of Alaska Hearing and Tinnitus Center and author of the clinic’s Real World Evidence Paper said, “Impressive clinical trial results for Lenire led me to early adoption of the landmark tinnitus treatment technology.”

“In my clinic, and my colleagues’ clinics, we are seeing results that are superior to clinical trial results.” Dr. McMahan continued.

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design, development, and commercialisation of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromoddevices.com.

About Tinnitus

Tinnitus, commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. Tinnitus affects an estimated 15% of the global adult population.

The management of tinnitus poses significant burden on healthcare systems. A 2021 study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion per annum. In the USA it’s estimated the Veterans Benefits Administration paid out approximately $5.8 billion through its Veterans Compensation benefits program for tinnitus in 2023.

The American Tinnitus Association, the leading advocacy body in the USA for people living with the condition, has recently revised its estimate that 50 million Americans live with tinnitus upward to 70 million.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire works by delivering mild electrical pulses to the tongue, through an intra-oral component called the ‘Tonguetip®’, combined with auditory stimulation through headphones. This combination drives changes in the brain to treat tinnitus. To date, the device has been used in large-scale clinical trials with over 700 patients.

Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo grant of approval by the US FDA. Further details about Lenire including a list of providers can be found at www.lenire.com.

Connect with Neuromod

LinkedIn: linkedin.com/neuromod
X: x.com/NeuromodDevices
Facebook: facebook.com/neuromoddevices/

References & Notes

(i) Baguely et al., Tinnitus, The Lancet (2013), sciencedirect.com/science/article/pii/S0140673613601427
(ii) Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
(iii) Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, doi.org/10.1038/s41598-022-13875-x (2022)
(iv) Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024)
(v) US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
(vi) McMahan, E.E. and Lim, H.H., 2024. Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States: A retrospective chart review. medRxiv., pp.2024-08; doi: https://doi.org/10.1101/2024.08.22.24312175 [preprint]
(vii) Tziridis K, Friedrich J, Brüeggemann P, Mazurek B, Schulze H. Estimation of Tinnitus-Related Socioeconomic Costs in Germany. Int J Environ Res Public Health. 2022 Aug 22;19(16):10455. doi: 10.3390/ijerph191610455. PMID: 36012089; PMCID: PMC9407899.
(viii) https://www.linkedin.com/posts/patrickalynch_tinnitus-activity-7270503831304654848-VbWN/

Mainstay Medical Announces Positive Outcomes from Landmark RESTORE Clinical Trial of ReActiv8®

• ReActiv8® Restorative NeurostimulationTM demonstrated statistically significant and clinically meaningful superiority vs. standard of care in all primary and secondary measures of disability, pain and quality of life

• Safety profile consistent with prior ReActiv8 clinical trials and favourable to other neuromodulation procedures

• ReActiv8 is now supported by the most complete and robust set of clinical evidence of any neuromodulation therapy for axial back pain globally.

Mainstay Medical Holdings plc today announced the publication of positive one-year primary assessment results of the RESTORE randomized clinical trial of ReActiv8 for the treatment of intractable chronic low back pain. The data show that the addition of ReActiv8 Restorative Neurostimulation therapy to current standard of care results in superior improvements in back pain-related disability, pain and quality of life compared to standard of care treatments alone. The results were published in Pain and Therapy, a leading peer-reviewed journal, and the article is available free of charge here: doi.org/10.1007/s40122-024-00689-0.

The study included 203 patients, with 99 randomized into the treatment arm and 104 randomized into the control arm. Key results from the study include:

• The primary endpoint of the mean improvement in Oswestry Disability Index (ODI) score between the treatment and control arms at the one-year follow-up visit (using mixed model for repeated measures (MMRM) for missing data) was statistically significant (p<0.001), with a clinically meaningful mean change in the ReActiv8 group compared to the control arm: ODI -19.7 ± 1.4 for the ReActiv8 group vs. -2.9 ± 1.4 for the control group.

• All secondary endpoints showed statistically significant differences between the ReActiv8 and control arms (using MMRM for missing data), as well as clinically meaningful improvements for the ReActiv8 arm, at one year, including:

  • Mean improvement in back pain measured using the 11-point Numeric Rating Scale (NRS): -3.6 ± 0.2 for the ReActiv8 group vs. -0.6 ± 0.2 for the control group (p<0.001); and

  • Mean improvement in healthcare related quality of life measured using the EQ-5D-5L assessment: +0.155 ± 0.012 for the ReActiv8 group vs. +0.008 ± 0.012 for the control group (p<0.001). The improvement in the ReActiv8 group resulted in a mean quality of life score approaching the average quality of life score from the overall US population.

• The proportion of patients who reached the composite endpoint of ∶15-point ODI improvement and/or ≥ 50% NRS improvement and no worsening in either measure at one year was 72% in the ReActiv8 group and 11% in the control group (p< 0.001).

• Pain remission, defined as NRS of ≤ 3 at one year, was observed in 52% of patients in the ReActiv8 group and in 6% of those in the control group.

• The profile of related adverse events was similar to previously reported ReActiv8 studies and favourable to other neuromodulation treatment procedures.

“This patient population has historically had extremely limited options beyond temporary palliative treatments and drugs. The results in this study demonstrated that ReActiv8 Restorative Neurostimulation provided superior improvements to the lives of patients above and beyond what is currently used to treat them,” said the steering committee of the RESTORE study, Dr. Frank Schwab, Dr. Chris Gilligan, Dr. Nagy Mekhail, and Dr. Kiran Patel. “These exciting results further validate ReActiv8’s restorative mechanism of action treating multifidus dysfunction, a primary underlying cause of mechanical chronic lower back pain in certain patients. Combining these impressive results with the newly-issued ICD-10 code for multifidus dysfunction, this study further demonstrates the ability of clinicians to confidently select and treat patients with chronic mechanical low back pain who were previously very difficult to treat.”

“These high-quality data showing the treatment benefit of ReActiv8 compared to the current standard of care meaningfully add to the growing body of clinical evidence regarding ReActiv8 and firmly establishes the critical role of this therapy in treating intractable mechanical low back pain patients. We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population,” said Jason Hannon, CEO of Mainstay Medical. “We look forward to leveraging these data, along with the compelling results from our ReActiv8-B clinical trial and our numerous other studies, to further engage payers in the United States to expand commercial insurance access to this transformational therapy, which has the potential to deliver significant reductions in overall healthcare costs. I would like to thank Drs. Frank Schwab, Chris Gilligan, Nagy Mekhail and Kiran Patel for acting as our steering committee for this important study, as well as each of the enrolling sites, investigators and all of the participating patients.”

About the RESTORE Clinical Study and the Steering Committee

The RESTORE (ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation) clinical study is a multi-center, prospective, randomized trial with one-way cross-over. A total of 203 patients were randomized and followed in the study at 23 leading centers in the U.S. Eligible patients were randomized to either optimized medical management or ReActiv8 Restorative Neurostimulation therapy plus optimal medical management. Patient-reported outcomes were collected at regular intervals out to the one-year primary endpoint assessment, at which time the patients in the control arm were offered implantation with the ReActiv8 system. Assessment of the patients will continue for an additional year.

The steering committee for the study consists of Dr. Frank Schwab, Chair of Orthopedic Spine Surgery at Lenox Hill Hospital and Chief of Orthopedic Spine Surgery for Northwell Health System; Dr. Chris Gilligan, Chief Medical Officer, Chief Quality Officer & Senior Vice President of Robert Wood Johnson University Hospital; Dr. Nagy Mekhail, Professor and Director of Evidence-Based Pain Management Research, Cleveland Clinic, and Professor of Anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; and Dr. Kiran Patel, Director of Pain Medicine, Lenox Hill Hospital and Founder & CEO, NYC Neuromodulation Center of Excellence.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction, which may be evidenced by imaging or physiological testing. Candidates for ReActiv8 are patients with multifidus muscle dysfunction who have failed other forms of therapy (including pain medication and physical therapy) and are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative NeurostimulationTM system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

PR and IR Enquiries:

LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com

FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel. : +353 1 765 0886
Email: mainstay@fticonsulting.com

Mainstay Medical
Corporate Communications
Email: Media@mainstaymedical.com

XyloCor Therapeutics Raises $67.5 Million in Series B Financing to Advance Clinical Development of Novel Gene Therapy in Cardiovascular Disease

• Financing round led by new investor Jeito Capital with participation from existing investors

• Proceeds will support two double-blind Phase 2 clinical trials of lead candidate, XC001, which has demonstrated transformative potential for treatment of refractory angina

XyloCor Therapeutics, Inc., (“XyloCor”), a clinical stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced the completion of a $67.5 million Series B financing.

New investment will support a randomized, double-blind Phase 2b clinical trial (EXACT-2) of XC001 (encoberminogene rezmadenovec), in refractory angina, using a new non-surgical method of endocardial administration via a novel injection catheter. The financing will also fund a second randomized, double-blind Phase 2 trial of XC001 as an adjunctive treatment to coronary artery bypass graft surgery (CABG). XC001 offers a new therapeutic approach for debilitating and chronic conditions that impact over one million people in the United States who have no treatment options.

New investor Jeito Capital, a global leading private equity fund, led the Series B financing round which also included existing institutional investors EQT, Fountain Healthcare Partners, and Lumira Ventures. Rachel Mears, Partner at Jeito Capital, will join the XyloCor Board of Directors.

“We are delighted to have Jeito Capital join our strong investor syndicate and Board of Directors,” said Al Gianchetti, president and chief executive officer of XyloCor Therapeutics. “The support of this prominent group of life sciences investors is recognition of the progress we have made and confidence in our ability to reach important milestones in the path ahead. With this financing, we can accelerate our clinical development of XC001, completing two phase 2 clinical trials, and achieve our mission to help people with cardiovascular disease who have no treatment options.”

XyloCor is pioneering the application of one-time gene therapy to address significant unmet treatment needs among underserved patients with cardiovascular disease. In its initial target indication in refractory angina, XC001 has demonstrated potential to transform outcomes for patients who have exhausted available treatment options and have a debilitating quality of life. Positive results from the recently published Phase 1/2 clinical trial (EXACT-1) demonstrate the disease-modifying potential of XC001 to relieve chest pain in patients with refractory angina by reducing ischemic burden, as published in Circulation: Cardiovascular Interventions.

Based on the foundation of efficacy and safety data for XC001 demonstrated in EXACT-1, XyloCor plans to launch a randomized, double-blind Phase 2b in refractory angina in 2025 to further build upon the clinically-meaningful evidence generated to-date. XyloCor intends to deploy a catheter‑based endocardial delivery of XC001 in the Phase 2b EXACT-2 study, eliminating the need for surgical administration in this population.

XyloCor also aims to initiate a second Phase 2 trial of XC001 in 2025 as an adjunctive therapy to augment the effectiveness of CABG: a procedure used to treat coronary artery disease. CABG is generally recommended when there are significant blockages in the major coronary arteries with the objective to improve oxygen-rich blood flow, resulting in improvement in cardiovascular disease symptoms and quality of life, and reduction in future cardiac events. There are approximately 400,000 CABG procedures performed annually in the United States, in which an estimated one-third of procedures result in incomplete coronary revascularization, which can result in increased mortality, hospitalizations, repeat revascularizations, and angina symptoms.

Administering XC001 during the CABG procedure is intended to promote the growth of new blood vessels in the areas of the heart not treated by the bypass grafts and therefore reduce symptoms and improve outcomes beyond the bypass alone. XyloCor plans to dose the first patient in the Phase 2 study by year end 2025.

“We are thrilled to support XyloCor as it advances its clinical trials to evaluate XC001 as a potential treatment for patients struggling with the burden of cardiovascular disease,” said Rachel Mears, Partner at Jeito Capital. “The company has strong support from an experienced leadership team, world-class cardiologists and scientists and has made impressive achievements in a short time in advancing its novel gene therapy approach. We look forward to collaborating with the company as it progresses to the next steps in its clinical program.”

About Jeito Capital

Jeito Capital is a global leading Private Equity fund with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports managers through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients’ access globally, especially in Europe and the United States. Jeito Capital has €534 million under management and a rapidly growing portfolio of investments. Jeito Capital is based in Paris with a presence in Europe and the United States. For more information, please visit www.jeito.life or follow us on LinkedIn or X.

About XC001

XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with ischemic heart disease may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one‑time, local administration. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About XyloCor

XyloCor Therapeutics, Inc. is a private, clinical‑stage biopharmaceutical company developing potential best‑in‑class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with ischemic heart disease for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Contacts:

Corporate and Investor Relations:
A. Brian Davis, XyloCor Therapeutics, Inc.
brian.davis@xylocor.com
610-541-2056

Media Contact:
Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

Vivasure Announces Positive Results of PATCH IDE Pivotal Study Indicating Safety and Efficacy of PerQseal® Large Hole Closure Device

• Data from U.S. IDE PATCH Pivotal Study presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference will support a pre-market approval submission to the FDA

• Results demonstrate Vivasure’s PerQseal® Closure Device achieved closure with very low rates of major vascular complications and rapid times to hemostasis

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced initial positive results from its U.S. IDE PATCH Pivotal Study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System, at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference in Washington, D.C.

The Vivasure PerQseal® Closure Device System (PerQSeal) is the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices. It is used for large hole arterial access and is needed for a variety of procedures including transcatheter aortic valve replacement (TAVR) and numerous other large hole cardiovascular procedures. The goal of the device is to reduce vascular complications while simplifying the closure.

Vivasure’s U.S. IDE PATCH Clinical Study, a multi-center, single-arm, pivotal study, enrolled over 145 patients across 17 U.S. and European investigational sites and evaluated the safety and efficacy of PerQseal when used to achieve hemostasis of common femoral arteriotomies created by 12 to 22F sheaths (arteriotomies up to 26F) in subjects undergoing percutaneous catheter-based interventional procedures.

Data presented at TCT show an impressively low 0.8% Valve Academic Research Consortium 3 (VARC-3) major complication rate at discharge in 124 patients included in the study’s primary intention-to-treat analysis. Times to hemostasis following percutaneous procedures were rapid, with a median time of zero minutes.

“Complications from large hole vascular closure remain vexing, impacting patients and requiring additional time and resources. As interventionalists, we need new technologies to improve both outcomes and procedural efficiency,” said William A. Gray, MD, principal investigator of the PATCH study and system chief in the division of cardiovascular disease at Main Line Health, Philadelphia. “The PATCH study results presented today show real promise for the PerQseal technology and positions it to meaningfully improve patient care.”

“We are addressing an unmet need in the market by delivering the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures that, for the first time, delivers a minimally invasive approach to conventional venous closure,” explained Andrew Glass, CEO, Vivasure Medical. “The results from our U.S. pivotal study, as well as the previous PerQseal studies, indicate that the PerQseal System is safe and effective for patients around the globe.”

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

The PerQseal® is not available for sale in the United States.

Mainstay Medical Announces New ICD-10 Diagnosis Code for Multifidus Dysfunction

Mainstay Medical today announced that the United States Centers for Disease Control and Prevention (CDC) has designated an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code specifically for multifidus dysfunction in the low back. The new diagnosis code – M62.85: dysfunction of the multifidus muscles, lumbar region – went into effect on October 1, 2024.

In response to an acute injury in the low back, the brain typically reduces the neural drive that activates the multifidus muscle, resulting in reduced multifidus activity. Because the multifidus muscle is a primary stabilizer of the lumbar spine, this inhibition can lead to joint instability and overload, exacerbating the problem and contributing to chronic low back pain (CLBP). The ReActiv8® Restorative Neurostimulation™ system is designed to provide electrical stimulation to the nerves activating the multifidus muscle, aid in restoring its function and facilitate recovery from CLBP. ReActiv8 is the only FDA-approved treatment for the management of intractable CLBP associated with multifidus muscle dysfunction.

“The CDC has recognized multifidus muscle dysfunction as a prominent cause of CLBP and is now providing clinicians a clearer pathway to specifically diagnose this condition. Multifidus dysfunction is a highly specific disease state that does not respond to palliative forms of stimulation, and we are excited that this new code provides for clear reflection of the underlying disease state,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

NEUROMARK® Treatment for Chronic Rhinitis Yields Significant Clinical Improvements

• PARAGON Study Shows NEUROMARK® Treatment Benefits Allergic and Nonallergic Rhinitis Patients

Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced the publication of positive six-month results from the PARAGON clinical study in Ear, Nose & Throat Journal. The study demonstrates that treatment with Neurent Medical's NEUROMARK® System, a radiofrequency ablation device indicated for chronic rhinitis, led to significant improvements in rhinitis symptoms, ear symptoms, and quality of life.

The PARAGON Study, a prospective, multicenter, singe-arm trial, enrolled 80 participants. The primary efficacy endpoint was the change in reflective Total Nasal Symptom Score (rTNSS) at 6-month follow-up. Additional assessments included Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction Symptom Evaluation (NOSE), and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ). Subgroup analyses were performed for participants with allergic and nonallergic rhinitis.

Key Efficacy Findings:

• The primary endpoint was met with a statistically significant improvement from baseline to 6 months in the rTNSS (p < .0001).

• 91% or participants achieved the minimal clinically important difference (MCID) of ≥1 point improvement in the rTNSS at 6 months.

• The ETDQ-7 score, which measures ear pressure, ear pain, clogged ears, ear problems with cold/sinusitis, crackling/popping, ringing in ears, and muffled hearing, was significantly improved at 6 months (p < .0001).

• The total NOSE score and all 5 subscores were significantly improved at all time points (p < .0001).

• The overall mini-RQLQ score and all domain scores demonstrated significant improvement at all follow-ups (p < .0001).

• Both allergic and nonallergic subgroups showed significant improvement in all outcome measures (rTNSS, ETDQ-7, NOSE, and mini-RQLQ) (p < .001), with no significant differences between subgroups.

Lead investigator, Dr. Greg Davis said, "This study provides significant evidence that the NEUROMARK System dramatically improves the symptoms of chronic rhinitis, especially runny nose and nasal congestion." He continued, "In addition, one of the exciting benefits of NEUROMARK, is that this procedure improves ear symptoms associated with Eustachian tube dysfunction. This is the first study to show that neuromodulation of the posterior nasal nerve improves these symptoms. I am proud of the research team and co-investigators, and look forward to seeing our long-term data in the future."

"We are very pleased with the results from the PARAGON study, which underscore the effectiveness of our NEUROMARK System in providing significant relief for patients suffering from chronic rhinitis, including patients with both allergic and nonallergic rhinitis" said Brian Shields, CEO of Neurent Medical. "This data reinforces our commitment to developing innovative, minimally invasive solutions that enhance patients' quality of life and address the growing need for more effective treatments for chronic sinonasal diseases."

The NEUROMARK® System is a groundbreaking, minimally invasive treatment option designed to target the underlying drivers of chronic rhinitis. With these promising clinical outcomes, Neurent Medical continues to pave the way for non-surgical interventions in sinonasal care.

For more information about the PARAGON study the full publication can be accessed online at: https://journals.sagepub.com/doi/epub/10.1177/01455613241285134

About the NEUROMARK® System

The NEUROMARK® System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radio frequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The system is engineered to gently apply controlled low-power RF energy to target regions of the nasal cavity to disrupt the parasympathetic nerve signals in order to reduce the inflammatory response, thereby reducing core symptoms such as congestion and rhinorrhea.

About Neurent Medical

Neurent Medical is pioneering innovative treatments for chronic inflammatory sinonasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. Its proprietary NEUROMARK® technology with a unique design and advanced smart algorithmic control, allows physicians to precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate chronic rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland, with US HQ in Braintree, MA. For more information visit www.neurentmedical.com.

Lenire Controlled Clinical Trial Results Published in Nature Communications

• FDA approval for the groundbreaking tinnitus treatment device, Lenire, was granted in March 2023 based on the success of the device’s large-scale controlled clinical trial, TENT-A3.1

• TENT-A3 demonstrated that Lenire is more effective at providing relief from bothersome tinnitus than sound therapy alone, which was the trial’s control.

• No device-related serious adverse events were detected during TENT-A3.1

• 88.6% of participants stated they would recommend Lenire to treat tinnitus.1

• Lenire is available through specialized clinics in the United States of America and Europe. Further details about Lenire® can be found at www.lenire.com.

Nature Communications has published the peer-reviewed results of Neuromod Devices’ TENT-A3 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3) clinical trial for the first and only FDA-Approved bimodal tinnitus treatment device, Lenire.

The results published in the clinical trial paper titled: Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial, were central to Lenire’s successful De Novo US FDA Grant approval.

Published TENT-A3 Paper: Nature Communications

Lenire is a bimodal neuromodulation device which has been shown to provide relief from tinnitus that can sustain for at least 12-months after treatment in large-scale clinical trials.2,3 Lenire’s bimodal neuromodulation pairs mild electrical pulses to the tongue through an intra-oral component called the Tonguetip® with auditory stimulation through headphones.

TENT-A3 – Lenire Controlled Clinical Trial Design

TENT-A3, Neuromod’s third large-scale clinical trial for Lenire, was a controlled trial. The controlled trial was conducted as part of Lenire’s De Novo submission to the US FDA at three independent sites between March and October 2022 with 112 enrolled participants.

TENT-A3 compared Lenire’s bimodal neuromodulation mechanism to sound therapy. The trial was designed and executed with guidance from the US FDA. Participants were given six weeks of sound-only stimulation as a control condition, followed by six weeks of bimodal treatment where tongue stimulation was added to the sound component.

As part of Lenire’s successful De Novo submission, Neuromod was required to demonstrate that Lenire’s bimodal neuromodulation provided additional clinically significant benefit for tinnitus when compared to sound-only stimulation. TENT-A3 demonstrated that Lenire is clinically superior to sound-only stimulation for the majority of patients with moderate or worse tinnitus.

TENT-A3 Clinical Trial Results

Clinical trial data from Lenire’s De Novo submission further showed that 70.5% of participants with moderate or worse tinnitus who experienced no clinically meaningful improvement from six weeks of sound-only stimulation reported clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire.5,7

The majority of participants with moderate or worse tinnitus who underwent six weeks of sound-only stimulation also reported that a further six weeks of treatment with Lenire provided additional benefit for their tinnitus.1,5

Tinnitus, commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated at least 25 million Americans6 are currently living with the condition. Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 2.9 million veterans compensated in 2023.4

“Tinnitus is the largest unmet need in hearing healthcare,” said Neuromod Founding CEO, Dr. Ross O’Neill Ph.D., “Historically, tinnitus patients have been disappointed and frustrated by products that are neither backed by compelling clinical evidence, nor cleared by regulatory authorities. With the success of TENT-A3 and the first-of-its-kind De Novo FDA-Approval, Lenire is the only tinnitus treatment backed by multiple large-scale clinical trials and approved by the US Food and Drug Administration.”

Lenire – A Category-Defining Tinnitus Intervention

In addition to the majority of participants benefitting from bimodal neuromodulation, 82.4% were compliant to bimodal treatment and 88.6% responded that they would recommend Lenire as a tinnitus treatment1.

“Lenire’s FDA Approval combined with the rigorous design of the device’s controlled clinical trial were compelling factors when choosing to add Lenire to the treatment options at my clinic. said Prof. Gail Whitelaw Ph.D., Clinic Director, Department of Speech and Hearing Science, The Ohio State University. “Lenire has been a landmark addition to my tinnitus toolbox and my patients have seen the benefits of overwhelmingly positive results.”

The positive efficacy, compliance, and safety findings for TENT-A3 were highly consistent with the real-world evidence from 204 patients included in Lenire’s successful De Novo submission to the US FDA. Across TENT-A3 and the Real-World Evidence, Lenire proved to be inherently safe with zero device-related serious adverse events1. These results build upon the success of two previous landmark clinical trials of Lenire that included more than 500 patients.2,3

“The TENT-A3 controlled clinical trial was properly designed with expert guidance from the US FDA.” said Neuromod Chief Scientific Officer and University of Minnesota Professor, Prof. Hubert Lim, Ph.D., “This interactive collaboration enabled the success of Lenire’s De Novo FDA approval, which has further established Lenire as a category-defining tinnitus intervention.”

References and Notes

1. Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024)

2. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

3. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)

4. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/

5. As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories. https://www.nidcd.nih.gov/health/tinnitus

6. https://www.nidcd.nih.gov/health/tinnitus

7. Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)

MMI Completes World’s First Robotic Preclinical Study in Neurosurgery with Symani® Surgical System

First-of-its-kind procedure a breakthrough in expanding robotic capability to complex neurosurgical care

MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced the completion of a preclinical study that demonstrated the feasibility of the Symani® Surgical System in neurosurgical procedures. Adnan Siddiqui, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of the Jacobs Institute and Vice Chair and Professor of Neurosurgery in the Jacobs School of Medicine and Biomedical Sciences, successfully repaired a blood vessel in the brain in an animal model using the Symani Surgical System, the first such robotic-assisted microsurgery demonstration in the brain.

“Dr. Siddiqui’s breakthrough demonstration showed the benefits of robotic precision and control when operating on brain tissue,” said Mark Toland, CEO of MMI. “The robotic platform allowed him to perform extremely delicate maneuvers deep in the skull cavity that would not have been possible with the human hand alone. The success of this procedure opens the possibility of expanding Symani’s reach into neurosurgery, a field of medicine that involves the most fragile anatomy and has yet to benefit from robotic-assisted microsurgical capabilities.”

The study aimed to both collect feedback on Symani from a highly experienced neurosurgeon and assess the feasibility of the platform as a tool to treat neurological conditions. It was performed at the Jacobs Institute, a nonprofit medical device innovation center located in Buffalo, N.Y., which aims to accelerate the development of next-generation technologies in vascular medicine.

“Symani offered added control that allowed me to access and repair a vein just under 1 millimeter in diameter, with clips spaced 4 millimeters apart,” said Dr. Siddiqui. “It required techniques that would be extraordinarily difficult for most micro-neurosurgeons to replicate without robotic assistance, using sutures so small they are barely visible to the naked eye. Based on this excellent initial experience, I have no doubt Symani could be highly effective during a wide range of complex neurosurgical procedures with the development of additional microsurgical tools. In fact, I believe it is ready for superficial temporal to middle cerebral artery bypass surgery today.”

The Symani Surgical System is designed to provide enhanced precision and control for the anastomosis and suturing of microscopic vessels with the thinnest available sutures. With the world’s smallest surgical robotic wrist, called NanoWrist®, Symani enables surgeons to replicate the natural movements of the human hand at the micro scale. It also features motion-scaling technology that reduces the hand’s scale of movement by as much as 20x, giving surgeons more freedom to operate on microscopic anatomy.

Surgeons have leveraged the Symani Surgical System in over 1,000 cases globally and more than two dozen publications highlight positive clinical outcomes. It is designed to help restore quality of life for patients, accelerate the number of surgeons able to push the boundaries of complex procedures for delicate anatomy, and enable hospitals to expand their open surgical programs.

The U.S. Food and Drug Administration (FDA) granted De Novo Classification to the Symani Surgical System in April 2024, making it the only commercially available platform in the U.S. for reconstructive microsurgery. It is available for commercial use in Europe and parts of Asia Pacific.

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

About MMI

MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair and lymphatic repair. In Europe and APAC, it also addresses peripheral nerve repair. The Symani System is authorized for use in the U.S. by the FDA and is a CE Marked medical device in Europe. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.

About the Jacobs Institute

The Jacobs Institute is a non-profit organization whose mission is to accelerate the development of next-generation technologies for vascular and neurologic diseases through collisions of physicians, engineers, entrepreneurs, and industry. The JI’s vision is to improve the treatment of vascular and neurologic disease in Western New York and the world, while fostering local economic development. The JI fosters medical collaboration and innovation through partnerships with the University of Buffalo (UB), Kaleida Health, and industry to be a fitting tribute to the work and memory of Lawrence D. Jacobs, MD. Additionally, the JI’s i2R, or Idea to Reality Center, is taking ideas for vascular and neurologic medical devices and moving them through the proof-of-concept process. Finally, the JI also increases physician and industry knowledge of vascular and neurologic diseases through clinical education programs.

Contacts

Media:
Dan Ventresca
Matter Health for MMI
MMI@matternow.com

Investor Relations:
Lisa Croke
Lisa.Croke@mmimicro.com

Mainstay Medical Announces Receipt of European and Australian Approvals of MRI Labeling on ReActiv8® Restorative Neurostimulation System

MRI clearances received in connection with certification of conformity with EU and UK Medical Device Regulations

Mainstay Medical Holdings plc today announced that it has received regulatory approvals in the European Union, the United Kingdom and Australia for full-body MR conditional labeling for the ReActiv8® Restorative Neurostimulation system. As a result, all current and future ReActiv8 patients in Europe and Australia implanted with the commercially available 45 cm leads have the ability to undergo 1.5T full-body scans. Specific scan conditions and safety information are provided in the ReActiv8 MRI Guidelines manuals for each territory.

The MRI approvals were achieved in connection with Mainstay receiving certificates issued by its Notified Body confirming conformity with the Medical Device Regulations (MDR) of both the European Union and the United Kingdom.

“These MRI approvals will allow us to significantly broaden access to ReActiv8 for patients in Europe and Australia who may require (or develop the need for) MRI imaging post-implantation, complementing our earlier approval of MRI labeling in the United States,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical. “In addition, we are proud of our continued commitment to patient safety and product quality, as shown by our being among the first in the neuromodulation field to achieve MDR certification for Europe and the UK.”

Customer information emails will be sent, and MRI Guidelines and related information will be available, next week.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

XyloCor Therapeutics and SmartCella Enter into License Agreement for Use of the Extroducer Infusion Catheter System to Administer Novel Gene Therapy XC001 to the Heart

• The Extroducer® Infusion Catheter System ® enables local delivery of XC001 to the heart without the need for surgery.

• XC001 has achieved positive Phase 1/2 results in the EXACT Trial validating its transformative potential for treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality-of-life.

XyloCor Therapeutics, Inc. (“XyloCor”), a clinical stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, and SmartWise, a unit of SmartCella Holding AB (“SmartCella”), have entered into a licensing agreement under which XyloCor has rights to the Extroducer® Infusion Catheter System ®, a first-in-class endovascular device designed to deliver advanced therapies directly into the heart. XyloCor plans to deploy the Extroducer to support catheter-based endocardial delivery of its lead gene therapy candidate, XC001 (encoberminogene rezmadenovec), in future clinical studies and commercial use.

“This agreement with SmartCella will enable XyloCor to build upon its robust foundation of efficacy and safety data for XC001 by offering the potential for improved safety and ease of delivery without surgery via this novel catheter,” said Al Gianchetti, President and CEO of XyloCor. “Teaming up with SmartCella will help in our effort to optimize patient safety and tolerability while maintaining accurate delivery of XC001 to target areas in the heart for patients with refractory angina. It also opens up the potential to develop XC001 earlier in the coronary artery disease progression for even larger patient groups.”

XC001 is designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple isoforms of vascular endothelial growth factor (VEGF). With the use of the Extroducer catheter, XyloCor can offer patients a better delivery option for local administration of XC001 directly to the heart, that is less invasive and eliminates potential risks associated with surgical administration.

“We welcome the Extroducer delivery of XC001 as it offers a more efficient method for gene therapy administration for patients with refractory angina,” said Timothy D. Henry MD, Interventional Cardiologist and Director of the Lindner Center, The Christ Hospital, Cincinnati, Ohio. “Preclinical models provide strong evidence that this approach will maintain, or even improve the efficacy when compared to surgical delivery and it should lower the risk of complications that may arise from surgical administration. I am looking forward to initiating the Phase 2b trial of XC001 in patients with refractory angina using this innovative administration approach.”

The recently published EXACT Phase 1/2 trial assessed the use of one-time gene therapy with XC001 as a new therapeutic approach in refractory angina – a debilitating and chronic condition that impacts over one million people in the United States and is growing in prevalence. In the EXACT trial, 42 patients with class II-IV angina were treated with XC001 directly administered to the heart following minimally invasive surgical access. The results demonstrated that treatment with XC001 can be safely administered and achieve durable clinical improvements of exercise duration, and angina frequency, due to a decrease in ischemic burden, as measured by Positron Emission Tomography (PET) imaging. Notably, six months after treatment 43% of patients had no chest pain with ordinary activities and 58% reported no angina episodes at 12-month clinical follow up. XC001 was well tolerated in the patient population and there were no serious adverse events related to the drug. The Phase 2b trial will be a randomized double-blinded study assessing the safety and efficacy of XC001 administered via the Extroducer® Delivery Catheter in coronary artery disease patients with refractory angina.

“The collaboration underscores the transformative potential of the Extroducer in delivering XC001 therapy for patients with refractory angina. A great example of a powerful combination of delivery system and drug therapy representing a substantial advancement in treatment options. The collaboration with such a distinguished partner as XyloCor marks a significant milestone for our global expansion efforts and will also enable us to further explore and harness the future capabilities of the Extroducer, ultimately expanding the benefits to a greater number of patients in need,“ said Niklas Prager, CEO of SmartCella.

Terms of the agreement include a global license to XyloCor for use of the Extroducer for the administration of XC001 and provide for SmartCella to supply catheters to XyloCor in clinical trials and commercial use in exchange for an upfront payment, clinical, regulatory and commercial milestones and a royalty on sales. Total deal value amounts to approximately USD 130 million and mid-single digit royalties.

About XC001

XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one time, local administration. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About Extroducer® Infusion Catheter System

The Extroducer® Infusion Catheter System is a first-in-class endovascular delivery device which enables direct-to-tissue drug delivery. The Extroducer® addresses a significant unmet need in the field of novel therapies, enabling targeted delivery of a wide range of modalities for solid tumor treatment, genetic disorders and tissue repair, to name but a few. Using standard equipment and routine interventional radiology approaches, the Extroducer provides access to hard-to-reach tissues by safely penetrating the vessel wall and delivering payload directly to the target location. Smartwise received U.S. Food and Drug Administration (FDA) clearance under 510(k) for the Extroducer® delivery catheter in June 2022.

About XyloCor

XyloCor Therapeutics, Inc. is a private, clinical stage biopharmaceutical company developing potential best in class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

About SmartCella

SmartCella, founded in 2014, is an innovative biotechnology company based in Stockholm, Sweden. SmartCella’s vision is to combine first-in-class delivery platforms with cutting-edge cell and mRNA therapies to unleash the full potential of targeted therapies. The company has three main business units, Smartwise, SmartCella Solutions and ProCella. For more information, visit www.smartcella.com.

MMI Builds Global Momentum with Multiple Distribution Agreements and Regulatory Approvals

Expansion includes fastest-growing market for microsurgical procedures and opportunity for considerable advancement, improved patient treatment options

MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced milestones across two continents that increase the global reach of the Symani® Surgical System.

The company announced:

• It reached an exclusive distribution agreement with Gunze Medical Limited, a leading developer and manufacturer of medical devices in Japan. The agreement signals a step toward commercializing Symani across Japan, upon regulatory approval, and will eventually enable hospitals there to expand their open surgical programs to include microsurgery and supermicrosurgery procedures.

• The Symani Surgical System has now received regulatory approvals in 35 countries around the world, most recently securing approvals in Hong Kong, Malaysia, New Zealand and Taiwan. They mark Symani’s latest regulatory milestones following the U.S. Food and Drug Administration authorizing the system for commercial use in April.

• It has expanded commercialization efforts in Europe by partnering with the Synektik Group, a leading integrator of innovative medical solutions that covers six countries across Eastern Europe. The agreement marks the next stage in bolstering Synektik’s standing as a top distributor of robotic medical systems in the region.

“The demand for innovative, less invasive, highly precise surgical options is increasing around the world, particularly in Asia, where microsurgery and reconstructive surgery both have long histories,” said Mark Toland, CEO of MMI. “Our recent regulatory approvals in multiple countries, and growing relationships with distributors in key markets, have enabled us to accelerate our timeline for global expansion. Each new milestone represents another step toward expanding patient access to highly advanced microsurgical capabilities around the world.”

The Symani Surgical System uniquely addresses the scale and complexities of microsurgery and supermicrosurgery, such as the anastomosis and suturing of small anatomical structures like blood and lymphatic vessels, during open surgical procedures. By allowing surgeons to replicate the natural movements of the human hand at the micro scale, it can help restore quality of life for more patients, accelerate the number of surgeons able to push the boundaries of complex procedures for delicate anatomy, and enable hospitals to expand their open surgical programs.

“Our partnership with MMI will facilitate the Symani Surgical System’s expansion into Japan,” said Shojiro Matsuda, President of Gunze Medical Limited. “We are deeply committed to expanding patient access to robotic-assisted microsurgery and believe Symani’s proven clinical success will complement our relationships with care provider organizations with expertise in plastic and reconstructive surgery.”

Asia-Pacific represents the fastest growing microsurgery market in the world, and Taiwan specifically is a hub of microsurgical innovation that attracts surgeons from around the globe. MMI has already signed a distributor agreement in the country to support its regulatory approval there and details are being finalized on the heels of the authorization.

“MMI’s mission to expand patient access to highly specialized microsurgical options perfectly aligns with our own as we help to further enable robotic capabilities across Poland and Eastern Europe,” said Cezary Kozanecki, founder and CEO of Synektik. “Symani has introduced a new level of capability and enabled surgeons to perform exceptionally precise procedures that include lymphedema repair, head and neck cancer-related reconstruction, and autologous breast reconstruction. Our health system partners have already expressed significant interest in expanding their open surgery capabilities to include procedures they haven’t been able to previously perform.”

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

About MMI

MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair and lymphatic repair. In Europe and APAC, it also addresses peripheral nerve repair. The Symani System is authorized for use in the U.S. by the FDA and is a CE Marked medical device in Europe. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.

Contacts

Media:
Dan Ventresca
Matter Health for MMI
MMI@matternow.com

Investor Relations:
Lisa Croke
Lisa.Croke@mmimicro.com