Corteria Pharmaceuticals announces initiation of Phase 1 study to evaluate CRF2 agonist COR-1167 for treatment of worsening heart failure

Corteria Pharmaceuticals (‘Corteria’), a clinical-stage biopharmaceutical company focused on the development of transformative therapies for heart failure and obesity, today announces the initiation of its Phase 1 study to evaluate the company’s first-in-class corticotropin-releasing hormone receptor 2 (CRF2) agonist, COR-1167, for the treatment of Worsening Heart Failure (WHF).

COR-1167 is a once-daily subcutaneous CRF2 agonist that has demonstrated substantial protective effects and functional improvement in the heart, vasculature and kidneys in multiple animal models of heart failure. Its unique mechanism of action offers a novel opportunity for treating WHF with the goal of alleviating cardiac congestion by restoring and maintaining stable cardiovascular and renal function.


The Phase 1 trial is a randomized placebo-controlled study with the primary objective of assessing the safety and tolerability of COR-1167 in both healthy volunteers and patients with chronic heart failure.


“The advancement of our lead CRF2 agonist into the clinic is a significant milestone in our mission to bring novel treatments to patients experiencing the debilitating effects of worsening heart failure,” said Philip Janiak, founder and CEO of Corteria Pharmaceuticals. “The preclinical data for COR-1167 is very promising and we are excited to determine its therapeutic potential in patients.”


Prof. Adriaan Voors, professor of cardiology at the University Medical Centre Groningen (Netherlands) and principal investigator of the study, emphasized that: “the initiation of this Phase 1 study with COR-1167, a CRF2 agonist, both in healthy volunteers and patients with heart failure is an important step in potentially reducing the burden of heart failure, especially for patients who experience worsening signs and symptoms despite being treated with currently recommended therapies.”


The company anticipates completing the Phase 1 study in the first half of 2025, to be followed by the initiation of a Phase 2 study in this indication.

About Worsening Heart Failure


The clinical course of heart failure is characterized by periods of clinical stability being frequently interrupted by episodes of worsening symptoms and signs, defined as Worsening Heart Failure (WHF). 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 Corteria Pharmaceuticals


Corteria Pharmaceuticals is a clinical-stage biopharmaceutical company developing first-in-class medicines for the treatment of heart failure and obesity. In addition to its lead daily CRF2 agonist, COR-1167, the company is advancing a long-acting CRF2 agonist for the chronic treatment of right heart failure and obesity, as well as an Arginine VasoPressin (AVP) neutralizing monoclonal antibody for the treatment of acute heart failure with hyponatremia. Worldwide, more than 60 million people live with heart failure and more than one billion with obesity, resulting in substantial morbidity and mortality.

Mainstay Medical Announces Publication of the First Neuromodulation Study for Low Back Pain with 5-Year Follow-Up

Groundbreaking ReActiv8-B study supports the long-term efficacy, safety and durability of ReActiv8® Restorative NeurostimulationTM for the treatment of intractable Chronic Low Back Pain

Mainstay Medical Holdings plc today announced the publication of the 5-year follow up from the ReActiv8-B randomized, sham-controlled, double-blinded trial. There were 126 patients who completed the 5-year follow up, and the published data clearly indicated that ReActiv8® Restorative Neurostimulation is a long-term, effective, durable, and safe therapy. ReActiv8 is the only restorative therapy for patients suffering from non-surgical, mechanical CLBP evidenced by multifidus dysfunction.

The publication is available here: https://www.sciencedirect.com/science/article/pii/S1094715924000552

The ReActiv8-B study saw multiple patients have their implants removed for resolution of back pain. These removals for success suggest a restorative mechanism, and the therapy shows no evidence of the loss of efficacy commonly observed with palliative treatments.

Dr. Chris Gilligan, Chief Medical Officer and Chief Quality Officer at Robert Wood Johnson University Hospital, stated: “The long-term, durable patient outcomes from this study are unprecedented in the field of neuromodulation. This is truly a unique therapy that is restorative in nature and does not show any of the loss of efficacy seen with other treatments in our field. With 5 year published outcomes, we are no longer limited to providing temporary or palliative treatments to our patients. ReActiv8 is changing the way we treat properly selected patients.”

Jason Hannon, CEO of Mainstay Medical, stated: "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. We look forward to sharing this data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy.”

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.

Mainstay Medical Announces Publication of Clinical Results Comparing Older Patients and Younger Patients

Efficacy of ReActiv8® Restorative Neurostimulation™ shows no statistically or clinically meaningful differences between older and younger patient populations.


Mainstay Medical Holdings plc today announced the publication of a pooled analysis of three different clinical studies that evaluated the safety and efficacy of ReActiv8 therapy after two years in patients of various ages. The analysis, published in Regional Anesthesia & Pain Medicine, included 261 patients across the ReActiv8-B, ReActiv8-C, and PMCF studies, with the results demonstrating that age is not a factor when utilizing ReActiv8 to treat intractable mechanical chronic low back pain patients with multifidus dysfunction.


The publication can be found here: https://rapm.bmj.com/content/early/2024/03/08/rapm-2023-105032


There were no statistically significant or clinically meaningful differences between the groups in the magnitude or durability of response across pain, disability, or health-related quality of life measures. A summary of some of the data from the analysis for patients at two years of ReActiv8 therapy is as follows:

Dr Simon Thomson MBBS FFPMRCA, Consultant Lead at the Pain and Neuromodulation Centre, Mid and South Essex University Hospitals NHS, Essex, UK and the London Clinic, former President of International Neuromodulation Society (INS), stated: “Restorative Neurostimulation has proven to be a unique therapy that delivers consistent results in randomized, controlled and real-world studies. Until now it was unknown if age was a factor in predicting long-term outcomes. This pooled analysis demonstrates that properly selected patients can benefit from this therapy, irrespective of age.”

Jason Hannon, CEO of Mainstay Medical, stated: “High quality clinical evidence sets us apart in this industry. We study, learn, and demonstrate outcomes in patient populations before we suggest ReActiv8 is beneficial to a particular group of patients. This is how we partner with clinicians to deliver the best possible, and most durable, treatments for their patients. With these exciting results demonstrating the value of ReActiv8 across all studied age groups, we can now confidently support identification of older patients who are likely to benefit from the therapy. We look forward to continuing to partner with physicians to help chronic low back pain patients of all ages, and to growing the global body of peer-reviewed evidence supporting the ability of ReActiv8 to provide positive long-term outcomes.”

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.


Mainstay Medical Announces US$125 Million Equity Financing Transaction

Funding to accelerate commercial growth and expand clinical and health economic evidence for ReActiv8® Restorative NeuromodulationTM System

Mainstay Medical Holdings plc today announced an equity financing in which it will receive gross proceeds of US$125 million. Mainstay intends to use the funds to support the company’s continued commercial growth of ReActiv8® Restorative Neurostimulation in the U.S., Europe and Australia, additional post-market clinical studies and research, and general operations.

The financing was co-led by new investors Gilde Healthcare and Viking Global Investors. Key existing investors who participated in the financing include Ally Bridge Group, Sofinnova Partners (Crossover Fund), Fountain Healthcare Partners, and Perceptive Advisors.

“A financing of this magnitude will allow us to accelerate our efforts to revolutionize the treatment of mechanical low back pain through ReActiv8 Restorative Neurostimulation, including by continuing our rapid commercial growth and building on our insurance coverage for ReActiv8,” said Jason Hannon, CEO of Mainstay Medical. “We are now strongly capitalized to execute on our corporate objectives. In addition to commercial expansion in our target markets, these objectives include the generation of additional clinical and health economic data to further demonstrate that ReActiv8’s purpose-built, restorative approach to the treatment of mechanical chronic low back pain is superior to competitive therapies originally designed for other indications, as well as the continued development and enforcement of our dominant intellectual property portfolio.”

“We are excited to lead this financing and to work with Mainstay to continue to unlock the potential of ReActiv8 therapy,” said Geoff Pardo, Partner at Gilde Healthcare, who also joins the Mainstay Medical Board of Directors. “Patients with mechanical chronic low back pain have had very limited treatment options, and the restorative mechanism of action offered by ReActiv8 is both unique and very promising.”

Two extraordinary general meetings of Mainstay shareholders were held on 23 February 2024 to approve the financing and related matters. At the EGMs, all resolutions were duly passed. The results of the voting on each of the resolutions is available on the Company’s website.

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.

MMI Raises $110 Million in Series C Financing

Largest ever investment in microsurgery will further MMI’s mission to transform open surgery with robotic technology

MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced that it has raised $110 million in Series C financing. The round, led by Fidelity Management & Research Company, marks the largest ever investment in microsurgery innovation.


The funds will support commercialization of the Symani® Surgical System in high-growth markets and continued investment in studies that generate clinical evidence and enable indication expansion. Investments will also accelerate advanced technology capabilities and enable MMI to scale its operational capabilities globally.


MMI and its existing investors, all of whom contributed to the Series C financing, see considerable opportunity for rapid growth. The company projects the market for eligible robotic microsurgical procedures will grow from 3 million to 22 million annually by 2028, driven primarily by technological advancements and indication expansion.


“Against a backdrop of plateauing investments in medical robotics, this support builds on our confidence in a new, less invasive solution for open surgery, a significant market that can benefit from the smallest wristed microinstruments,” said Mark Toland, CEO of MMI.Our Symani Surgical System is uniquely positioned to expand patient access to care by accelerating the number of surgeons able to perform complex, delicate procedures. With the support of our investors, we will continue to advance our technology through a growing body of clinical evidence and expanded hospital partnerships.”


The Symani Surgical System is a first-of-its-kind robotic technology that uniquely addresses the scale and complexities of microsurgery and supermicrosurgery. By allowing surgeons to replicate the natural movements of the human hand at the micro scale, it can expand treatment options for patients in need of soft tissue, open surgical procedures, such as free flap reconstructions, lymphatic surgery, and trauma replantations. It is designed to 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.


MMI has raised over $200 million in funding to date. In 2022, it closed a Series B financing round to propel growth. The funding was allocated to help expand indications and support ongoing commercialization efforts for the Symani Surgical System in Europe, where it received CE mark in 2019, accelerate plans to commercialize in the U.S. and Asia-Pacific, and advance clinical research.


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, lymphatic repair, and peripheral nerve repair. The Symani System is CE Marked for commercial use in Europe. In the United States, the system is not approved or cleared for commercial use. 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.

Mainstay Medical Announces Receipt of FDA Approval for MRI Labeling on ReActiv8® Restorative Neurostimulation SystemTM

U.S. patients implanted with ReActiv8 now eligible for full-body MRI scans

Mainstay Medical Holdings plc today announced that the U.S. Food and Drug Administration (FDA) has approved full-body MRI conditional labeling for the ReActiv8® Restorative Neurostimulation system. This approval applies to all current and future ReActiv8 patients in the United States implanted with the current 45 cm commercially-available leads.


The approval provides patients implanted with ReActiv8 the ability to undergo 1.5T full-body MRI scans. Specific scan conditions and safety information are provided in the ReActiv8 FDA MRI Guidelines manual.


“This approval expands the existing safety profile of ReActiv8, broadening access to patients who may need (or develop the need) for MRI imaging after implant,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical. “The ReActiv8 MRI labeling is one of the most comprehensive among neurostimulation devices approved for chronic low back pain, with full-body imaging at 1.5T at normal operating mode (maximum specific absorption rate (SAR) of 3.2 W/kg for the head and 2.0 W/kg for the rest of the body). We look forward to building on this as we seek conditional MRI compatibility in Europe and Australia.”

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.

Inotrem Successfully Reaches Agreement with the FDA for a Phase 3 Registration Trial for Nangibotide in Septic Shock

  • Novel biomarker-guided Phase 3 registration trial in septic shock with an enrichment strategy-based patient selection.

  • Historic paradigm shift in Primary endpoint: from all causes of mortality at Day 29 to proportion of patients alive and free of organ support at Day 29

Inotrem, an advanced clinical stage biotech company specializing in immunotherapies for acute and chronic inflammatory syndromes, today announced the outcome of its regulatory interactions with the US Food and Drug Administration (FDA) to finalize the design of a single Phase 3 registration trial (ACCURATE) for nangibotide in septic shock. The ACCURATE trial design is built upon Phase 2 (ASTONISH) data that confirmed nangibotide’s strong efficacy and safety profile. The FDA accepts Inotrem’s innovative biomarker-driven precision medicine approach.


The ACCURATE study will be centered on patients with high risk of mortality and morbidity as defined by a high concentration of the blood based sTREM-1 biomarker representing about 50 percent of the septic shock patients. This unique biomarker-guided approach allows for a single Phase 3 registration trial with a manageable number of subjects. The overall size of ACCURATE will be about 1,300 patients, with a primary analysis group of 900 patients. The primary endpoint of ACCURATE will be the proportion of patients alive and free of organ support at Day 29. ACCURATE will run globally and enroll patients in about 100 sites in the Americas, Europe and Japan.


Inotrem is collaborating with Roche Diagnostics since 2017 to develop a sTREM-1 assay on the Elecsys/COBAS platform to identify patients that are both more at risk and more likely to benefit from nangibotide treatment. All sTREM-1 measurements in ACCURATE will be carried out on the Roche platform paving the way for the test to be available as a companion diagnostic at the time of nangibotide approval.


“Inotrem is now in a leading position to conduct a single Phase 3 registration trial in a prospectively defined population of septic shock patients that are at high risk of morbidity and mortality. Our innovative, biomarker-guided strategy along with a new patient-related primary endpoint gives us the best possible chance of success in this challenging indication,” said Margarita Salcedo-Magguilli, Chief Development Officer of Inotrem.


“The successful End of Phase 2 meeting with the FDA is a testament to the dedication and expertise of our team. We are energized by the support and guidance from the FDA which will enable us to accelerate the development of nangibotide and, ultimately, bring a potentially transformative treatment to septic shock patients in need of new alternatives," added Sven Zimmermann, Chief Executive Officer of Inotrem.


Septic shock is the ultimate complication of sepsis and constitutes a high unmet medical need. The incidence of septic shock continuously raises and mortality remains elevated: it is the main cause of death in intensive care units. There is currently no specific therapy approved for this indication. Inotrem’s solution has the potential to become the first mechanism-based treatment for septic shock. With nangibotide, Inotrem has developed a novel approach of immunomodulation targeting the TREM-1 pathway to restore appropriate inflammatory response, vascular function and improve post septic shock survival. Based on its scientific leadership on TREM-1, next to acute inflammatory syndromes, the company has expanded its TREM-1 franchise into chronic inflammatory diseases.

About Inotrem

Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, nangibotide, with potential applications in life-threatening immune dysregulations caused by severe infections such as septic shock and severe forms of COVID-19. In parallel, Inotrem has also launched an antibody-based program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr Marc Derive. Inotrem is supported by leading European and North American investors. Inotrem is part of the French Tech 120, a government program dedicated to support the development of fast-growing startups. www.inotrem.com

Contacts

Media contact for Inotrem
Anne REIN
Strategies & Image (S&I)
anne.rein@strategiesimage.com
+33 6 03 35 92 05

Calypso Enters into Agreement to Be Acquired by Novartis

  • Calypso is a European biotech translating Interleukin-15 biology into medical breakthroughs by developing CALY-002, an anti-IL-15 monoclonal antibody, for an array of autoimmune indications

  • The acquisition of Calypso gives Novartis full rights to CALY-002, a pipeline-in-a-drug with potential in dermatology, gastro-intestinal and rheumatology indications


Calypso Biotech BV (‘Calypso’), a leader in the development of Interleukin15 (IL-15) targeted therapies, announced today that it has entered into an agreement to be acquired by Novartis AG (‘Novartis’). Calypso’s shareholders will receive an upfront payment of $250 million upon closing and are eligible to receive development milestones of up to $175 million based on the achievement of certain predetermined milestones.


Calypso, a spin-out from Merck, is focused on the research and development of monoclonal antibodies for an array of autoimmune indications, with an expertise in IL-15 biology. IL-15 is a broad, untapped immune axis that controls barrier function and downstream immune cascades in many chronic autoimmune diseases. Calypso’s lead product candidate, CALY-002, is a potential best-in-class therapeutic antibody that binds to and neutralizes Interleukin-15.


The acquisition gives Novartis full rights to CALY-002. Novartis intends to further explore CALY-002 across a wide variety of autoimmune indications with high unmet medical need. CALY-002 is currently evaluated in a Phase 1b trial in patients with Celiac Disease and Eosinophilic Esophagitis.


Alain Vicari, Chief Executive Officer & Co-Founder, Calypso, commented: “We are excited for this transaction with Novartis, a company with relentless commitment to the development of innovative therapies for autoimmune conditions. As part of the Novartis portfolio, CALY-002 is in the best position to be developed effectively, so that it can promptly address unmet medical needs in multiple indications”


Bernard Coulie, Chairman, Calypso, commented: “The transaction with Novartis constitutes the high point in the development path of CALY-002 for the Calypso team. Calypso has established a significantly de-risked profile for CALY-002 as a potential best-in-class therapeutic anti-IL-15 antibody”


Richard Siegel, Head of Immunology Research at Novartis, commented: “Novartis is committed to bringing innovative treatment options forward for patients living with immunological diseases. We’re thrilled to add Calypso’s potential best-in-class antibody to our Immunology pipeline and explore it in a spectrum of autoimmune indications.”


Lazard acted as financial advisor and Goodwin Procter LLP acted as legal counsel to Calypso.

About Calypso Biotech BV

Calypso is a private biotechnology company focused on the research and development of novel biologics to address unmet medical need in autoimmune and inflammatory diseases.

Calypso is developing a novel anti-IL-15 monoclonal antibody to treat a broad range of chronic autoimmune diseases by blocking Interleukin-15 (IL-15) and its wide-ranging functions at many levels of the immune response cascade. CALY-002, a highly potent monoclonal antibody, neutralizes all forms of IL-15 through a uniquely effective molecular mode of action to reduce inflammation and prevent tissue destruction.

Calypso was founded by M Ventures, the corporate strategic venture arm of Merck, and is headquartered in Amsterdam, The Netherlands, with offices and laboratories in Geneva, Switzerland. Investors include M Ventures, Inkef Capital, Gilde Healthcare, Fountain Healthcare Partners and Johnson & Johnson Innovation – JJDC, Inc.

Contact

Calypso Biotech BV
info@calypsobiotech.com

Corteria Pharmaceuticals appoints Mark Pruzanski as Chairman of its Board of Directors

Corteria Pharmaceuticals (“Corteria”), a biopharmaceutical company specialized in the development of transformative therapies for heart failure and obesity, today announced it has appointed Mark Pruzanski, MD, as Chairman of its Board of Directors. He replaces Thierry Laugel, Managing Partner at Kurma Partners, who remains a member of the Board.

Dr. Pruzanski has more than 30 years of experience as a life sciences executive, entrepreneur and investor. He most recently served as Chairman and CEO of Versanis Bio, a private clinical-stage biopharmaceutical company focused on the development of new medicines for the treatment of obesity and other cardiometabolic diseases, which was acquired by Eli Lilly in July 2023. He founded Intercept Pharmaceuticals and was the company’s CEO until 2021, having led its evolution from drug discovery stage to a global development and commercial organization with a focus on addressing chronic liver diseases. He serves as a Board member of several private and public biotechnology companies, the Emerging Companies Section of the Biotechnology Innovation Organization (BIO), and the Foundation for Defense of Democracies, a non-profit policy institute focusing on foreign policy and national security.


Dr. Pruzanski received his M.D. from McMaster University in Hamilton, Canada, a M.A. degree in International Affairs from the Johns Hopkins University School of Advanced International Studies in Bologna, Italy and Washington, D.C., and a bachelor’s degree in Political Science from McGill University in Montreal, Canada.


“We are thrilled to welcome Mark as the Chairman of the Board of Directors,” said Philip Janiak, founder and CEO of Corteria Pharmaceuticals. “Mark brings extensive expertise in drug development with a solid track record in the biotechnology industry. His strategic vision, outstanding leadership and passion for innovation make him a valuable addition to Corteria as we continue our mission to advance innovative therapeutic solutions for heart failure and obesity.”


“It’s a privilege to join the Board of Corteria,” said Mark Pruzanski. “This is an exciting time in the company’s evolution as it brings its exciting first-in-class assets into the clinic and on the heels of its recent Series A financing led by top tier biotech investors. I am looking forward to working with Philip and the rest of the Board to help ensure Corteria’s future success.”

About Corteria Pharmaceuticals

Founded in 2021, Corteria is a privately held biopharmaceutical company developing first-in-class drugs with an initial focus on the treatment of heart failure. Despite improvements in the management of this serious disease, the prevalence of heart failure keeps increasing with more than 60 million patients worldwide and there are large subpopulations of patients who are poorly served by currently available treatments.


More information available at: www.corteriapharma.com

Investors/media contacts

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


Andrew Lloyd & Associates
Juliette Schmitt / Celine Gonzalez
juliette@ala.associates / celine@ala.associates
UK: +44 1273 952 481
US: +1 203 724 595

US FDA grants Orphan Drug Designation to mocravimod to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with hematologic malignancies

  • Mocravimod is the only S1P receptor modulator being developed as an adjunctive and maintenance treatment for blood cancers

  • Mocravimod is being investigated in a global registration-enabling Phase 3 trial

  • This is the second Orphan Drug designation for mocravimod

Priothera Ltd., a Phase 3 clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation (ODD) to mocravimod for the ‘treatment to improve outcome following hematopoietic stem cell transplantation in hematologic malignancies’. This ODD aims to potentially increase leukemia-free survival by enhancing a graft-versus-leukemia (GvL) response.

Florent Gros, Co-Founder and CEO of Priothera, commented: “We are very pleased that the US FDA granted mocravimod this Orphan Drug designation. This designation emphasizes the importance of developing novel therapeutic options to improve the outcome and success of maintenance therapy following allo-HSCT in blood cancer patients. This is an important milestone as this ODD complements the first ODD granted for prevention of graft-versus-host disease.”

“The two ODDs highlight mocravimod’s dual mode of action which for the first time is being leveraged to improve the allo-HSCT treatment outcomes in hematological malignancies to potentially increase the leukemia free survival – graft-versus-leukemia response - while reducing tissue damage resulting from the graft-versus-host disease.”

The first ODD granted for mocravimod by the US FDA was for the ‘prevention of graft-versus-host disease (GvHD)’ – see press release here.

Mocravimod, a sphingosine-1-phosphate (S1P) receptor modulator, is being investigated in a pivotal global Phase 3 study - MO-TRANS (NCT05429632) - evaluating the efficacy and safety of mocravimod as an adjunctive and maintenance therapy to allo-HSCT. The study which is enrolling approximately 250 adult Acute Myeloid Leukemia (AML) patients, is ongoing in the US, Europe, Southeast Asia and Latin America.

Mocravimod, which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of allo-HSCT. Moreover, it has shown a clinically meaningful outcome in a Phase 1b/2a study[1] in patients with hematologic malignancies undergoing allo-HSCT.

The Orphan Drug designation is reserved for medicines treating rare, life-threatening or chronically debilitating diseases.

About mocravimod

Mocravimod (also known as KRP203) is a synthetic, S1P receptor modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers and the improvement of CAR-T cell therapy.

Mocravimod is currently being investigated as an adjunctive and maintenance treatment in a Phase 3 study for patients with AML receiving allogeneic HSCT. Allogeneic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages mocravimod’s dual mode of action to maintain the beneficial graft-versus-leukemia/lymphoma (GvL) activity, while reducing tissue damage resulting from graft-versus-host disease (GvHD), both a consequence of allo-HSCT. This novel treatment approach – mocravimod being the only S1P receptor modulator treating blood cancers – tackles a high unmet medical need and aims to improve patients’ quality of life.

About Priothera

Priothera is leading the way in developing orally applied S1P receptor modulators for the treatment of hematological malignancies and for the improvement of CAR-T cell therapies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues. Unlike immunosuppressive drugs, mocravimod does not suppress the GvL benefits in patients receiving allogeneic HSCT while inhibiting GvHD.

Priothera was founded in 2020 by an experienced team of drug development experts and is headquartered in Dublin, Ireland, and with a subsidiary in Saint-Louis, France. The Company is backed by international founding investors Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden), EarlyBird Venture Capital (Berlin, Germany), as well as non-dilutive financing in the form of loans from the European Investment Bank under its Venture Debt Instrument and Bpifrance (Grand Est Bpifrance) in the form of a R&D innovation loan.

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

Contacts

Priothera
Florent Gros, CEO
E: info@priothera.com

MEDiSTRAVA Consulting
Sylvie Berrebi, Sandi Greenwood, Frazer Hall
E: priothera@medistrava.com
T: +44 (0) 203 928 6900

[1]*Ref: Dertschnig et al, 2023

Vivasure Medical Announces 100th Patient Enrolled in U.S. Pivotal Study

PATCH Clinical Study will evaluate the safety and efficacy of Vivasure’s PerQseal Closure Device System for large-bore vessel punctures

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System. The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval earlier this year to advance the PATCH study forward.

"We’re grateful to the one hundred patients who have been enrolled in this study to date and the brilliant physician investigators working to gather data about our technology," said Andrew Glass, Chief Executive Officer of Vivasure Medical. "This marks an important milestone for Vivasure as it brings us closer to our goal of demonstrating PerQseal’s potential in supporting successful percutaneous cardiovascular therapies."

Large hole arterial access is required for clinicians to perform numerous life-saving percutaneous cardiovascular procedures such as transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device (CAD). The current approach to large-diameter arterial closure is a surgical repair or the use of suture- or collagen-based closure devices. Both can result in major vascular complications, such as vessel distortion at the closure site, which may lead to stenosis, thrombus formation or abrupt closure.

PerQseal is designed to be the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Its low profile patch can be placed from inside the vessel and is intended to make deployment simpler and more controlled than conventional closure techniques. Clinical studies to date have shown a low complication rate and high technical success.

The PATCH pivotal study will enroll and follow up to 188 patients across the U.S. and Europe. The company intends to use the clinical study results to support an FDA pre-market approval submission as well as multinational commercial launch of the PerQseal system for large hole vessel closure.

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.

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

Neurent Medical Announces New CPT Code® for Chronic Rhinitis Treatment Offering Significant Symptom Improvements

CMS Assignment Empowers ENT Physicians and Offers Relief to Millions of Chronic Rhinitis Patients

Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced a significant milestone for the chronic rhinitis market. The Centers for Medicare and Medicaid Services (CMS) has recently assigned a Category I Current Procedural Terminology (CPT®) reimbursement code for a breakthrough minimally invasive procedure designed to address the symptoms of patients suffering from chronic rhinitis.

Effective January 1, 2024, the assigned payment for CPT code 31242 for endoscopic destruction of the posterior nasal nerve (PNN) using radiofrequency ablation will be instated for use with Neurent Medical's NEUROMARK® System. The new code describes the procedure performed by otolaryngologists or ear, nose, and throat (ENT) physicians when disrupting overactive nerves that drive chronic rhinitis symptoms.

Marc G. Dubin, MD, FACS, a nationally recognized subspecialist in sinus and nasal disease expressed his enthusiasm for this upcoming assignment, stating, "The establishment of this CPT code is a significant milestone for physicians who treat chronic rhinitis patients with ablation of the posterior nasal nerves as we are now able to provide patients lasting relief and address chronic runny nose, post-nasal drip, and congestion more effectively." He continued, "I have been fortunate to use the NEUROMARK System throughout its development and with its demonstrated safety and efficacy in the recently published CLARITY study, I am eager to have this treatment option readily available to my chronic rhinitis patients who have had limited options for long term treatment to-date."

It is estimated that several million chronic rhinitis patients are seen by ENT doctors annually in the United States. The condition affects approximately one in four Americans1. Chronic rhinitis patients endure sinonasal discomfort characterized by persistent congestion, rhinorrhea (runny nose), sneezing, and nasal itching due to inflammation and swelling mucosal membrane in the nose. The high prevalence of chronic rhinitis and its negative impact on day-to-day life, including sleep, cognitive function, mood, and ultimately on performance at work or school, make chronic rhinitis a global public health issue2.

Currently available treatments have been shown to be effective in interrupting posterior nasal nerves (PNN). However, not all patients have adequate resolution of their symptoms. One hypothesis for this lack of improvement is inadequate treatment of nerves due to natural anatomic variations that are not addressed by current devices3.

The NEUROMARK System offers ENTs a novel and unique flexible leaflet design to help achieve precise placement across the PNN and accessory pathways. The proprietary Smart Algorithms monitor the treatment of targeted tissue to ensure it is delivered adequately to the intended area. The system can comfortably accommodate a range of anatomies. Microlesions disrupt the PNN pathway while maintaining mucosal and vascular integrity.

The significance of this milestone is further emphasized by Neurent Medical's CEO, Brian Shields, who commented, "The assignment of the CPT Code marks the next chapter of evolution and growth for Neurent Medical. We are extremely proud to be at the forefront of innovation, introducing a sustainable treatment option for patients who are suffering with chronic rhinitis." He added, "The NEUROMARK System uses a proprietary algorithm and biofeedback to tailor treatment for each individual patient. This achievement reflects our commitment to enhancing patient outcomes and our partnership with clinical investigators and the otolaryngology community as a whole."

The NEUROMARK System received U.S. Food and Drug Administration (FDA) 510(k) clearance in October 2021 and Neurent Medical announced the limited market release of the system in February 2023.

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 Radio Frequency (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 algorithmic control, physicians can 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 the US office located in Braintree, MA. For more information visit www.neurentmedical.com.


1 Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23-34. PMID: 17153005.

2 Vandenplas O, Vinnikov D, Blanc PD, et al. Impact of Rhinitis on Work Productivi.: A Systematic Review. J Allergy Clin Immunol Pract. 2018;6(4):1274-1286.e9. doi:10.1016/j.jaip.2017.09.002

3 Fan T, Chandna M, Gorelik D, et al. Correlation between middle turbinate insertion in relation to sphenopalatine foramen and failure rates of cryotherapy and radiofrequency treatment for chronic rhinitis. Int Forum Allergy Rhinol. 2023;13(1):88-91. doi:10.1002/alr.23058

MMI Expands Global Footprint with Entry into Asia Pacific Market

Partnerships with Device Technologies and TRM Korea will strengthen Symani® Surgical System’s entrance into the world’s fastest-growing surgical robotics market.

MMI, (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced that it will continue its global momentum with two distribution agreements covering nearly a dozen countries in the Asia Pacific (APAC) region. The first partnership, with Device Technologies, will help to introduce the Symani Surgical System to Hong Kong, Singapore, Vietnam, Malaysia, Indonesia, Thailand, Philippines, Macau, and New Zealand, upon applicable regulatory approvals, as well as Australia, where it recently received approval from the Therapeutic Goods Administration (TGA). The other partnership, with TRM Korea, will facilitate the system’s entry into South Korea upon regulatory approval and will introduce microsurgical robotic technology to interested surgeons and hospitals.

The Symani Surgical System is a first-of-its-kind robotic technology that uniquely addresses the scale and complexities of microsurgery and supermicrosurgery. By allowing surgeons to replicate the natural movements of the human hand at the micro scale, it can expand treatment options for patients in need of soft tissue open surgical procedures, such as free flap reconstructions, lymphatic surgery, and trauma reconstructions. It is designed to 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.

“Through our new partnerships in Asia Pacific, we have established roots that will ultimately help us expand patient access to robotic microsurgical and supermicrosurgical capability in a region of the world with clear demand for the technology,” said Matt Lemay, VP of Asia Pacific of MMI. “Surgeons from the APAC region have long been at the forefront of innovation in microsurgery, and we look forward to helping further those capabilities with the Symani Surgical System. As we advance our mission of increasing treatment options for patients with complex conditions, we are enthusiastic about our global progress and look forward to continuing our momentum in APAC and beyond.”

Device Technologies has provided healthcare professionals access to innovative, high quality medical devices, including leading robotics solutions, for over 30 years. They will open a new research and education center for robotic microsurgery with a premier medical institution as part of their partnership with MMI. The center will represent the first site in Central Asia where interested surgeons can learn more about the system.

“MMI and the Symani Surgical System are well aligned with our core mission to provide physicians and healthcare facilities with solutions that can drive improved patient outcomes,” said Heath Priestly, Managing Director at Device Technologies. “Originating in Australia, we have broadened our presence throughout the Asia Pacific region, establishing expertise and strong connections. We are eager to use our footprint to support MMI’s health system partnerships across the region and further increase patient access to sophisticated surgical techniques for complex conditions.”

TRM is the largest microsurgery company in South Korea and a pioneer in the medical technology and innovation space. They are collaborating with a world-renowned medical institution to open their own education center where surgeons will have the opportunity for informational sessions and hands-on learning about the Symani Surgical System. To learn more about MMI, visit 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, lymphatic repair, and peripheral nerve repair. The Symani System is CE Marked for commercial use in Europe. In the United States, the system is not approved or cleared for commercial use. MMI is backed by international medtech investors including Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.

MMI’s Symani® Robotic Surgical System Surpasses 500 Clinical Procedures

  • Milestone case performed at HUS Helsinki University Hospital demonstrates MMI’s continued momentum in the soft tissue open surgery field

MMI, (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced the successful completion of over 500 in-human surgeries with the Symani® Surgical System in the European Union. The Symani Surgical System is a first-of-its kind robotic technology that uniquely addresses the scale and complexities of microsurgery and supermicrosurgery. It aims to 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.

Millions of patients today with complex conditions lack access to treatment options that optimize outcomes due to human physical limitations on the microsurgical scale and a lack of specialists able to perform surgery on tiny, delicate anatomy. The Symani Surgical System is poised to help. It is a robotic platform that enables expanded options for patients in need of soft tissue open surgical procedures, such as free flap reconstructions, lymphatic surgery, trauma reconstructions, and peripheral nerve repairs. Since the first in-human cases in October 2020, the system has been used in over 500 procedures, rapidly increasing patient access to surgical treatment options as surgeons become comfortable using the technology.

“We believe that open surgery is long overdue for technological advancement. This major milestone for the Symani Surgical System is a testament to how robotics can elevate the standard of care by pushing the boundaries of complexity,” said Mark Toland, CEO of MMI. “People with hard-to-treat conditions deserve options that can give them a better quality of life, and we hope that by expanding access to microsurgical and supermicrosurgical procedures, we’re able to drive that initiative forward.”

The Symani Surgical System’s unique capabilities in open microsurgery are a result of its proprietary NanoWrist® instruments, which feature the world’s smallest surgical robotic wrist. This enables surgeons to replicate the natural movements of the human hand at the micro scale with seven degrees of freedom, tremor filtration, and motion scaling, ultimately increasing precision and control.

The 500th procedure was a lymphatic repair performed by Sinikka Suominen, PhD, MD, plastic surgeon at the HUS Helsinki University Hospital in Finland. HUS Helsinki University Hospital is one of the largest University Hospitals in Europe and is also a European and International Microsurgery Centre of Reference. In 2023, it was ranked No. 39 on Newsweek’s list of the World’s Best Hospitals. Of the 500 procedures completed to date, approximately 75 percent have been free flap surgeries, and 16 percent have been lymphatic repairs. The remaining 9 percent have consisted of other procedures such as peripheral nerve repairs and extremity replantation surgeries.

“Our hospital is using the Symani Surgical System across multiple procedure types, such as lymphatic repair and head and neck cancer-related reconstructive surgery, and I’ve experienced notable changes in the accuracy, stability, and reliability of my suture placement during lymphatic procedures,” said Dr. Suominen. “These are quality of life surgeries that enable patients to return to work or simply resume their normal daily activities. Lymphedema at its worst is a disabling condition, and advanced microsurgical procedures can give patients hope for a better quality of life. I’m proud to have completed this milestone procedure and look forward to many more opportunities to help patients through open, robotic microsurgery.”

To learn more about MMI, visit http://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, lymphatic repair, and peripheral nerve repair. The Symani System is CE Marked for commercial use in Europe. In the United States, the system is not approved or cleared for commercial use. MMI is backed by international medtech investors including Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.

Contacts

Dan Ventresca
Matter Health for MMI
mmi@matternow.com

Corteria Pharmaceuticals Announces a €65M Financing to Advance Transformational Medicines in Cardiovascular Diseases

Corteria Pharmaceuticals (“Corteria”), a biopharmaceutical company specialized in the development of transformative therapies for unaddressed heart failure subpopulations, today announced an oversubscribed €65M ($71M) Series A co-led by US investment firm OrbiMed and EU-based leading investment firm Jeito Capital, with the participation of all existing seed investors (Kurma Partners, Fountain Healthcare Partners, V-Bio Ventures, Invivo Capital, Omnes Capital). As a result, Erez Chimovits from OrbiMed and Andreas Wallnoefer from Jeito Capital will join the board of Directors of Corteria.

The funding will be used to advance Corteria’s cardiovascular pipeline into the clinic.

Heart failure is a serious disease with a prevalence of more than 60 million patients globally and still growing. Corteria’s innovative approach is centered on selecting therapeutic targets involved in the worsening and acute forms of human heart failure, as well as a stratification strategy to identify specific subgroups that are most likely to benefit from the treatments. These forms of heart failure are widespread, life-threatening, and not directly addressed by the current standards of care.

Corteria was founded in 2021 by Sanofi’s former head of cardiovascular research, Philip Janiak, and Marie-Laure Ozoux, former cardiovascular project leader at Sanofi, around two cardiovascular programs in-licensed from Sanofi.

Since then, Corteria’s pipeline has expanded rapidly and comprises today three first-in-class therapies that are highly differentiated as they produce multi-organ benefits, acting on the kidneys, the heart, and the vessels:

  • A once daily subcutaneous Corticotropin-releasing hormone receptor 2 (“CRF2”) agonist for the treatment of Worsening Heart Failure

  • A once monthly subcutaneous CRF2 agonist for the treatment of Right Heart Failure

  • An AVP (arginine vasopressin) neutralizing monoclonal antibody for the treatment of Acute Heart Failure with Hyponatremia

The lead asset for Worsening Heart Failure is expected to enter the clinic in early 2024.

“This financing marks a major milestone in our mission to bring therapies to heart failure subpopulations with high unmet needs,” said Philip Janiak, Founder and President of Corteria Pharmaceuticals. “We are extremely grateful to Jeito and OrbiMed as our new investors for their trust in our science and team and to our existing investors for their support and commitment since inception. We are looking forward to working all together to develop next generation transformative therapeutics.”

Andreas Wallnoefer, Partner at Jeito Capital, said: “Despite current treatments, heart failure is a progressing disease that impacts severely the lives of many patients and remains one of the leading causes of mortality worldwide. Corteria focuses on translating important therapeutic innovation in cardiology into clinical practice. Our investment in Corteria reflects Jeito’s commitment to address significant unmet needs in the realm of cardiology. We are excited to join forces with Corteria’s dedicated team to develop a portfolio of medicines with important clinical benefit for patients.”

“We are proud to have been involved with Corteria since its early days and impressed with the progress made to date. The company is now at a turning point of entering the clinic with its lead asset early next year and validating its unique positioning in well-defined heart failure subpopulations with high unmet medical needs. Kurma Partners is pleased to continue supporting the company during this key step that we hope will bring transformative clinical outcome for patients,” said Thierry Laugel, Managing Partner at Kurma Partners, and Chairman of the board of Corteria.

About OrbiMed

OrbiMed is a healthcare investment firm, with over $17 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. www.orbimed.com

About Jeito Capital

Jeito Capital is a global leading Private Equity company 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 @Jeito_life on Twitter or LinkedIn.

About Corteria Pharmaceuticals

Founded in 2021, Corteria Pharmaceuticals is a privately held biopharmaceutical company developing first-in-class drugs in heart failure subpopulations. Despite some improvements in the management of this serious disease, the prevalence of heart failure keeps increasing with more than 60 million patients worldwide. Corteria’s strategy involves innovative patient stratification and target selection based on human evidence and a better understanding of disease biology in patients with a focus on worsening and acute heart failure and right heart failure. More information available at: www.corteriapharma.com

Investors/media contacts

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


Andrew Lloyd & Associates
Saffiyah Khalique / Celine Gonzalez
saffiyah@ala.associates / celine@ala.associates
UK: +44 1273 952 481
US: +1 203 724 595

Mainstay Medical Announces Completion of Enrollment of RESTORE Clinical Trial of ReActiv8® in the United States

Randomized controlled clinical trial expected to validate effectiveness of ReActiv8® Restorative NeurostimulationTM vs. optimal medical management

Mainstay Medical Holdings plc today announced the completion of enrollment in its RESTORE randomized clinical study of ReActiv8 for the treatment of intractable chronic low back pain. The study is designed to provide a direct comparison to optimized medical management for the purpose of testing the hypothesis that the addition of ReActiv8 Restorative Neurostimulation therapy to current care paradigms results in significant improvements in back pain-related disability.

The RESTORE (ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation) clinical study is a prospective, randomized controlled trial conducted at 25 leading centers in the U.S. Eligible patients were randomized to either continue with their optimal medical management or ReActiv8 Restorative Neurostimulation therapy plus optimal medical management. Patient-reported outcomes are being collected at regular intervals out to the one-year primary endpoint, at which time the patients in the control arm are offered implantation with the ReActiv8 system. The Co-Principal Investigators of the RESTORE study are 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, Director of the Spine Center at Brigham and Women’s Hospital and assistant professor of Anesthesia at Harvard Medical School; and Dr. Kiran Patel, Director of Pain Medicine, Lenox Hill Hospital and Founder & CEO, NYC Neuromodulation Center of Excellence.

Jason Hannon, CEO of Mainstay Medical, stated: “We are proud to have reached this important milestone in the RESTORE clinical trial as we continue to demonstrate the clinical efficacy and positive economic impact of ReActiv8. We expect the initial data readout from the study in the second half of 2024, and we look forward to sharing the data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy. I would like to thank Dr. Frank Schwab, Dr. Chris Gilligan, and Dr. Kiran Patel for acting as Co-Principal Investigators of this important study, as well as each of the enrolling sites and all of the participating patients.”

“This type of randomized, controlled clinical trial in this difficult-to-treat and underserved patient population will produce high-quality data comparing ReActiv8 to the current standard of care,” said Drs. Frank Schwab, Chris Gilligan, and Kiran Patel, Co-Principal Investigators of the RESTORE study. “Once the data is published, it will meaningfully add to the growing body of clinical evidence regarding ReActiv8 and firmly establish the role of this therapy in treating mechanical low back pain patients.”

Drs. Schwab, Gilligan, and Patel continued: ”The RESTORE trial represents a substantial addition to the clinical evidence behind treatment options for this patient population who have extremely limited options beyond temporary palliative treatments and drugs. Directly addressing the underlying issue of muscular dysfunction can represent a substantial advancement in treatment options. We would like to express sincere thanks to the patients who agreed to be screened for this study, the trial investigators and their hard-working staff, and the Mainstay team for their passion and commitment to the program. We look forward to the results of this trial to prove the degree to which ReActiv8 can improve the lives of these patients above and beyond what is currently used to treat them.”

About the RESTORE Clinical Study

The RESTORE clinical study is a multi-center, prospective, randomized trial with one-way cross-over. A total of 226 patients were randomized in the study at 25 leading centers in the U.S. Eligible patients were randomized to either continue with their optimal medical management or ReActiv8 Restorative Neurostimulation therapy plus optimal medical management. Patient-reported outcomes are being collected at regular intervals out to the one-year primary endpoint, at which time the patients in the control arm are offered implantation with the ReActiv8 system. Assessment of the patients will continue for an additional year.

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 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 Presents Phase 2 Data Highlighting Safety and Efficacy of XC001 at the European Society of Cardiology (ESC) Congress 2023

  • Positive Phase 2 EXACT Trial results at 6-months underscore significant potential of investigational therapy in refractory angina

  • Six-month data have since been sustained out to 12-months supporting durability of XC001 safety and efficacy profile

  • XC001 targets unmet medical need among patients with refractory angina who have a debilitating quality-of-life burden and no available treatment options

XyloCor Therapeutics, Inc., a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today presented results from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) of its lead gene therapy candidate XC001 (encoberminogene rezmadenovec) for refractory angina at the European Society of Cardiology (ESC) Congress 2023. During the ESC Congress poster session, Dr. Thomas Povsic, Principal Investigator of the EXACT trial, presented the primary six-month outcome data from the recently completed EXACT trial, which demonstrated that treatment with XC001 resulted in improvements across all key efficacy endpoints. The findings underscore its strong potential as a novel therapeutic approach for the treatment of this disabling condition.

XC001 is a one‑time gene therapy designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple vascular endothelial growth factor (VEGF) isoforms. In the Phase 2 portion of the EXACT trial, 32 patients with class II-IV angina were dosed with the maximal dose of XC001 through transepicardial delivery (direct administration to the heart). XC001 met all of its safety and exploratory objectives and showed potential transformative benefits for the patient population. Among the notable topline results presented at the ESC Congress 2023 included:

  • VEGF gene therapy with XC001 administered via minimally invasive transepicardial delivery was generally well tolerated.

  • There were no serious adverse events related to the drug or unexpected serious adverse events related to XC001 administration.

  • Patients demonstrated improvements in key efficacy measures most notably total exercise time, time to the development of ST-depression (an objective measure of ischemia), angina frequency, and reduction in ischemic burden as measured by Positron Emission Tomography (PET) imaging.

  • The six-month results showed that XC001 achieved a clinically meaningful biologic effect, warranting further study in larger randomized clinical trials.

“Refractory angina is a debilitating and chronic condition that is growing in prevalence and these patients have exhausted all treatment options,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “The six-month results from the EXACT trial – which have now been sustained out to 12 months – demonstrate that gene therapy with XC001 has the potential to be safely administered while improving quality of life for these cardiac patients.”

“The clinical research results presented at ESC Congress 2023 highlight XyloCor's continuing efforts to transform the treatment paradigm in refractory angina through the promise of one-time gene therapy,” said Al Gianchetti, President and CEO of XyloCor. “We are excited to share data that provides evidence for angiogenesis and a promising efficacy and tolerability profile for XC001. These results strongly support our continued development of this novel therapeutic approach.”

Further background and results presented in the ESC Congress 2023 poster session titled “Angiogenic gene therapy for refractory angina: Results of the Epicardial delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) Phase 2 Trial” can be found here.

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 the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial was a Phase 1/2 multicenter, open‑label, single‑arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, followed by an expansion phase of the trial in which additional subjects were enrolled at the highest tolerated dose (1 x 1011 vp, the highest tested dose). In the EXACT trial, this investigational gene therapy is administered directly to the heart muscle through a mini‑thoracotomy by a cardiac surgeon.

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 grafting (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 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.

Results from XyloCor Therapeutics’ Phase 1 Portion of EXACT Trial of XC001 for Cardiovascular Disease Published in Circulation: Cardiovascular Interventions

  • Findings from the Phase 1 dose escalation portion of the EXACT trial of XC001 in refractory angina provided the dose selection and safety justification for the recently completed Phase 1/2 study

  • XC001 is a one-time gene therapy candidate designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple VEGF isoforms

  • XyloCor is moving forward with urgency to address potential of XC001 as transformative therapy for patients with ischemic heart disease with significant unmet need

XyloCor Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, announced today that Circulation: Cardiovascular Interventions has published results from the Phase 1 portion of its Phase 1/2 clinical trial (EXACT) of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina. The findings from the Phase 1 dose escalation study, previously reported at the American Association for Thoracic Surgery (AATS) and the American Society of Gene and Cell Therapy (ASGCT) in May 2022, revealed that XC001 is well tolerated at all dose levels and provided justification to proceed to Phase 2 with the highest dose tested.

“The results from the Phase 1 study provided the mechanistic underpinning that was the catalyst for the successful completion of the Phase 2 EXACT trial,” said Thomas Povsic, M.D., Ph.D., lead author of the journal article, Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “Patients with refractory angina are highly symptomatic and have an exceedingly poor quality of life. With a robust body of positive and sustained safety and efficacy out to 12 months from the EXACT trial, we believe that XC001 has the potential to fill the significant unmet need for this patient population who currently lack treatment options.”

"We are thrilled with the publication of these EXACT trial results in Circulation: Cardiovascular Interventions, a highly-regarded and influential international journal for cardiovascular research," said Howard Dittrich, Chief Medical Officer of XyloCor. “We would like to acknowledge all of the authors for their contributions in highlighting the promise of XC001 and thank patients and their families for their participation in the EXACT trial. Our team is singularly focused on continuing to unlock the transformative potential of XC001 for improving outcomes in cardiovascular disease.”

The Phase 1 portion of the Phase 1/2 EXACT study was a first-in-human, multicenter, open-label, single-arm, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of increasing doses of XC001, and to establish the best dose to carry forward for additional study in Phase 2. Twelve patients were enrolled into four dosing cohorts. Notably, the study demonstrated that adenoviral vector doses higher than those used in previous studies were well tolerated and more robust efficacy was demonstrated at the higher doses. This established a dose of 1×1011 viral particles for future clinical research of XC001.

The Circulation: Cardiovascular Interventions full article is available at https://www.ahajournals.org/doi/abs/10.1161/CIRCINTERVENTIONS.123.012997

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 the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial was a Phase 1/2 multicenter, open-label, single-arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, followed by an expansion phase of the trial in which additional subjects were enrolled at the highest tolerated dose (1 x 1011 vp, the highest tested dose). The investigational gene therapy is administered directly to the heart muscle through a mini-thoracotomy by a cardiac surgeon.

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 grafting (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 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.

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

Mainstay Medical Announces Publication of Three-Year Clinical Trial Data from Post-Market Clinical Follow-up Registry of ReActiv8® in the United Kingdom

Further real-world evidence supporting the efficacy and use of ReActiv8® Restorative NeurostimulationTM for the treatment of intractable Chronic Low Back Pain

Mainstay Medical Holdings plc today announced the publication of three-year clinical data from the Post-Market Clinical Follow-up (PMCF) study of 33 ReActiv8 patients from five medical centres across the United Kingdom. The three-year results, published in British Journal of Pain, demonstrated that a substantial portion of patients experienced statistically significant improvements in measures of pain (NRS), disability (ODI) and quality of life (EQ-5D-5L). The publication can be found here: https://journals.sagepub.com/doi/10.1177/20494637231181498.

These results indicate that the response to ReActiv8 for these patients is durable and improves over time, validating ReActiv8’s restorative mechanism of action. In addition, these real-world outcomes are consistent with the three-year data from the pivotal ReActiv8-B clinical trial, announced in September 2022, as shown in the following table:

Dr. Simon Thomson MBBS FFPMRCA, Consultant Lead at the Pain and Neuromodulation Centre, Mid and South Essex University Hospitals NHS, Essex, UK, stated: “These results demonstrate durability and safety of this therapy in chronic back pain sufferers who would have continued to be crippled and dominated by their symptoms but for ReActiv8. These patients, drawn from usual UK Pain clinics, are now as good as those seen in the continuation cohort from the more highly selected randomised ReActiv8-B trial.”

Jason Hannon, CEO of Mainstay Medical, stated: “We are pleased to add these compelling results to the growing global body of positive peer-reviewed evidence supporting the ability of ReActiv8 to provide positive long-term outcomes to this severely affected patient population. Most importantly, the continued improvement in patient outcomes observed in the real-world setting is consistent with the results from our controlled clinical trials.”

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 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.

XyloCor Therapeutics Reports Sustained Results in 12- Month Extension of Phase 2 EXACT Clinical Trial of XC001 Novel Gene Therapy for Refractory Angina

  • XC001 demonstrated durable improvements across multiple efficacy measures 12 months after treatment, underscoring its scientifically-sound approach to achieve biological effect and improve angina symptoms

  • Patients showed continued improvements in exercise capacity and reductions in episodes of chest pain that were sustained to 12 months

  • Robust body of mechanistic evidence from EXACT trial highlights significant potential of XC001 in cardiovascular disease

XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today reported positive 12-month data from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) designed to assess the safety and provide preliminary evidence of efficacy of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina.

At the 12-month mark in the extension period of the trial, XC001 demonstrated durable improvements across multiple efficacy measures, including continued improvement in total exercise duration and reductions in ischemic burden and ischemic symptoms.

Earlier this year, XyloCor reported positive results from the primary study period for the Phase 2 portion EXACT trial at six months. New results at 12 months highlight significant, clinically-meaningful impacts that are now sustained out to 12 months, pointing to the potential of XC001 as a novel therapeutic approach for the significant unmet medical need in refractory angina.


“The durability and, in the case of exercise time, continued improvements observed at 12 months signals a sustainable activity which is an exciting step forward in the advancement of gene therapy for cardiovascular disease,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “These 12- month data build upon the positive results achieved at the 3- and 6-month marks of the trial. In total, the outcomes of the EXACT study form a robust body of mechanistic evidence to propel the next stage of XC001’s development, suggesting that a single treatment may have long-term benefit.”

XC001 is a one-time gene therapy candidate designed to reduce ischemic burden by creating new blood vessels in the heart. The six-month primary study period in the Phase 2 portion of the EXACT trial was followed by a month 12 follow up period. At 12 months, patients demonstrated sustained and continued increases in total exercise duration (TED) over baseline, representing a significant and clinically meaningful change. In addition, there was a sustained and robust decrease in episodes of chest pain (angina) and nitroglycerin use. Cardiac imaging at 12 months provided additional evidence of the potential mechanism of action to achieve a biological effect, confirmed by a sustained reduction in ischemic burden observed over time.

“With the 12-month results from our EXACT trial, XyloCor continues to take a lead role in fulfilling the promise of gene therapy for people with cardiovascular disease,” said Al Gianchetti, President and CEO of XyloCor. "These results further enhance our confidence that we are on the right path for transforming outcomes in cardiovascular disease.”

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 the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial was a Phase 1/2 multicenter, open-label, single-arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, followed by an expansion phase of the trial in which additional subjects were enrolled at the highest tolerated dose (1 x 1011 vp, the highest tested dose). The investigational gene therapy is administered directly to the heart muscle through a mini-thoracotomy by a cardiac surgeon.

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 grafting (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 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