TRiCares Announces Successful First in Human Implantation of Minimally Invasive Topaz Tricuspid Heart Valve Replacement System in Germany
TRiCares Announces Successful First in Human Implantation of Minimally Invasive Topaz Tricuspid Heart Valve Replacement System in Germany
Paris, France and Munich, Germany, April 25, 2022 – TRiCares SAS (“TRiCares”) a privately held pioneer in the field of minimally invasive treatment of tricuspid regurgitation, today is pleased to announce the successful first in human implantation of its Topaz transfemoral tricuspid heart valve replacement system (“Topaz”) in Germany.
Heart valve diseases are among the most serious cardiac conditions, affecting more than 12.7 million patients in Europe and many more worldwide. In the last decade minimally invasive catheter-based solutions have been developed for other heart valve diseases, but none have been designed specifically for the tricuspid valve.
Tricuspid regurgitation is a frequent and serious disease for which open heart surgery and symptomatic pharmacologic treatment are the current standard treatment options. Owing to high mortality risk, access to open heart surgery is severely restricted and is not considered an option for more than 99 % of patients with tricuspid regurgitation. The prognosis for patients without surgical repair is poor, with 2.2 years median survival. As such, there is an urgent need for minimally invasive, lower risk solutions to improve outcomes for patients with no other viable treatment options.
Topaz is an innovative device designed specifically to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The Topaz device is the result of a French and German collaboration and is implanted in a minimally invasive procedure through the patient’s femoral vein. It is designed specifically to fit the tricuspid valve anatomy and thus supports ease of positioning and functionality.
Today’s announcement marks the successful first in human implantation of Topaz in a patient in Germany, which was done as a compassionate use treatment.
The procedure in Germany was performed for a 76-year-old woman with heart failure due to massive tricuspid regurgitation that recurred despite a previous suture annuloplasty of the tricuspid valve in 2014. The patient has a history of multiple cardiac surgeries like mitral valve replacement and bypass surgery, and has numerous risk factors that made a surgical treatment too hazardous. The successful implantation of the Topaz tricuspid heart valve replacement system took place at University Hospital Mainz in Germany, on 8 April 2022, and was performed by Prof. Ralph Stephan von Bardeleben. Prof. Hendrik Treede, cardiac surgeon at University Hospital Mainz, and Prof. Ulrich Schäfer, interventional cardiologist of the military hospital in Koblenz, Germany proctored the procedure. After an implantation time of 25 minutes the Topaz prosthesis anchored safely in the significantly enlarged ventricle and achieved complete correction of the tricuspid regurgitation. The patient recovered quickly from the intervention and was discharged from hospital after eight days.
In total nine implantations of the Topaz tricuspid heart valve replacement system have been performed to date across Europe.
Building upon the success of these procedures, TRiCares is preparing a clinical study in the coming months to confirm the value of its Topaz tricuspid heart valve replacement system for these types of patients, who until now have had no satisfactory treatment option.
Prof. Dr. Ralph Stephan von Bardeleben, Head of Heart Valve Center Mainz at University Hospital Mainz, commented, “I am delighted to have conducted the first implantation of the Topaz tricuspid valve replacement system in Germany. This patient, like the vast majority of patients with tricuspid regurgitation, had no other viable treatment options. It is tremendous to have successfully treated her using the innovative Topaz system, which provided perfect seating and valve functionality, and I hope this will be available in future for all patients in need.”
Prof. Dr. Treede, Director of the Department of Cardiac and Vascular Surgery at the University Medical Centre in Mainz, who proctored all Topaz procedures that were performed until now, commented, “I am very pleased to have attended all of the implantations of the Topaz tricuspid heart valve replacement system, which represents a significant improvement in the treatment of patients with tricuspid regurgitation.”
Helmut Straubinger, CEO of TRiCares, commented, “I am very glad to announce the first successful implantation of our Topaz tricuspid heart valve replacement system in Germany. I am proud of our team for developing an innovative treatment possibility for severely ill patients suffering from tricuspid regurgitation with no other treatment options. This successful implantation together with the results of further eight compassionate use cases give us confidence in our development and in taking the next steps.”
About TRiCares
Founded in 2013, TRiCares is a medical device startup company headquartered in Paris, France, with its operating location in Munich, Germany. The team’s vision is to bring to the market a transfemoral tricuspid valve replacement system to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The company is supported by leading European life science venture capital firms: Andera Partners, BioMedPartners, Credit Mutuel Innovation, GoCapital, Karista and Wellington Partners.
About Tricuspid Regurgitation (TR)
The tricuspid valve is the heart valve that regulates the blood between the right atrial and ventricular chamber. Tricuspid regurgitation occurs when the tricuspid valve fails to close properly, causing blood to flow backwards into the right atrium. Tricuspid regurgitation is a frequent problem and a severe disease that was neglected for many years, leading to a large number of untreated patients without an effective treatment option. Cardiac surgeons and interventional cardiologists have long waited for a transcatheter based solution to help patients suffering from severe TR.
About the Medical Need
Heart valve diseases are among the most serious cardiac complications affecting more than 12.7 million patients in Europe. In the last decade, innovative minimally invasive catheter-based solutions have been developed for the treatment of aortic and mitral heart valve disease, creating a fast-growing transcatheter heart valve replacement market. However, for patients with tricuspid heart valve disease (tricuspid regurgitation), no such solutions exist due to anatomic, functional and technological challenges specific to this so-called “forgotten valve”. Consequently, open-heart surgeries to repair the insufficient valve and medical treatments currently represent the standard treatment options. Due to excessive risk of the procedures (10–35 % surgical mortality), more than 99 % of TR patients are considered ineligible for the curative surgeries and are only maintained on symptomatic pharmacologic treatment with poor prognosis (2.2 years median survival). Therefore, cardiac surgeons are urgently seeking minimally-invasive, low-risk solutions to improve clinical outcomes in TR patients with no other viable treatment option.
For further information please contact:
TRiCares SAS
Helmut J. Straubinger,
President and
Chief Executive Officer
Consilium Strategic Communications
Matthew Cole
T: +44 (0)20 3709 5700
eGenesis Promotes Michael Curtis, Ph.D., to Chief Executive Officer
eGenesis Promotes Michael Curtis, Ph.D., to Chief Executive Officer
eGenesis Promotes Michael Curtis, Ph.D., to Chief Executive Officer
Dr. Curtis succeeds Paul Sekhri, who remains on Board of Directors.
Reflects company’s focus on advancement of portfolio toward clinical development.
CAMBRIDGE, Mass., April 19, 2022 – eGenesis, a biotechnology company developing human-compatible organs and cells for the treatment of organ failure, today announced the promotion of Michael Curtis, Ph.D., to Chief Executive Officer (CEO). Dr. Curtis succeeds Paul Sekhri who remains on the Board of Directors.
Dr. Curtis has served as President of Research & Development at eGenesis since joining the Company in 2020. He brings to eGenesis more than 25 years of scientific research and leadership experience in biopharmaceuticals across numerous companies and therapeutic areas. Dr. Curtis joined eGenesis from Cadent Therapeutics, where he served as President and Head of R&D. During his tenure at Cadent, the company developed a pipeline of novel therapies for the treatment of psychiatric and movement disorders leading to its acquisition by Novartis at the end of 2020.
“It has been a privilege to manage our research and development efforts under Paul’s leadership these past eighteen months,” Dr. Curtis said, “The team is focused on our mission of solving the organ shortage crisis. I am excited to continue advancing that mission and I am grateful for the confidence shown in me by the Board and my colleagues at eGenesis.”
Paul Sekhri former President and Chief Executive Officer and current Board member of eGenesis said, “I have seen Mike accelerate our engineering, production and preclinical development efforts during his tenure at eGenesis, and I am confident that he is the leader to advance our programs toward the clinic. I look forward to continue working with Mike as a member of the Board as we work toward the day when no one dies while waiting for a transplant.”
The timing of the transition coincides with the company’s efforts to advance multiple programs toward clinical development. The company recently appointed Dr. Eliezer Katz as Chief Medical Officer of eGenesis to lead medical operations and support preparation of programs for the clinic.
Outgoing CEO Paul Sekhri has led eGenesis since 2019, overseeing efforts that brought in $225 million for the company in support of the development of its platform, an acquisition in 2020 to vertically integrate donor production, and the expansion of the eGenesis team and operations.
“Paul has been critical in developing eGenesis into the company we are today,” said Steven Gillis, Ph.D., Chairman of the Board of Directors of eGenesis. “After more than 25 years as a biotechnology industry leader, Paul will focus on providing guidance to multiple life science companies. Mike has been successfully advancing our R&D programs since joining the Company in 2020. His elevation to the CEO role is a natural step for him and provides leadership continuity at eGenesis. The Board, management and the rest of the team are excited about his promotion and look forward to his leadership as we advance our programs toward clinical development.”
About Transplantation and Xenotransplantation
The demand for lifesaving organs far outnumbers available supply. In the U.S. alone, more than 100,000 people are on the national transplant list. Twenty people die every day due to lack of available organs for transplant and every 10 minutes, a new name is added to the national transplant waitlist.
The concept of xenotransplantation (the transplantation of organs and cells from one species to another) has been explored for decades. However, virology and immunology hurdles prevented the field from advancing beyond early preclinical research. With the advent of cutting-edge gene editing technologies, addressing these historical challenges is now within reach.
About eGenesis
eGenesis’ goal is to transform the field of transplantation by offering safe and effective organs and cells to patients in need. The company harnesses gene editing technology including CRISPR to address the key issues that have impeded xenotransplantation to date. eGenesis’ development pipeline includes lead programs for kidney and islet cell transplant as well as earlier-stage programs focused on other solid organs. Learn more at eGenesisbio.com.
Contacts:
Investors/Media
Investors
Eric Ando / Dr. Grace Kim
Burns McClellan, Inc.
212-213-0006
/
Media
Robert Flamm, Ph.D. / Katie Larch
Burns McClellan, Inc.
212-213-0006 ext. 364
/
ONWARD Announces Additions to Leadership Team
ONWARD Announces Additions to Leadership Team
Lara Smith Weber to join the company as CFO and Zouhir Mechta to join as VP Operations.
EINDHOVEN, the Netherlands & LAUSANNE, Switzerland—April 13, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announces Lara Smith Weber will join the company as its Chief Financial Officer and Zouhir Mechta will join the company as its Vice President Operations
PEI Regulatory Approval Received for Government Funded (€ 7.4 Million) Clinical Trial Investigating Adrenomed’s Adrecizumab in Treating Endothelial Barrier Dysfunction in Hospitalized COVID-19 Patients
PEI Regulatory Approval Received for Government Funded (€ 7.4 Million) Clinical Trial Investigating Adrenomed’s Adrecizumab in Treating Endothelial Barrier Dysfunction in Hospitalized COVID-19 Patients
PEI Regulatory Approval Received for Government Funded (€ 7.4 Million) Clinical Trial Investigating Adrenomed’s Adrecizumab in Treating Endothelial Barrier Dysfunction in Hospitalized COVID-19 Patients
- Adrecizumab selected to receive funding from two COVID-19 drug development programs of the German Federal Ministry of Education and Research (BMBF)
- By restoring vascular integrity, Adrecizumab addresses the endothelial barrier dysfunction as a consequence of severe COVID-19
- University Medical Center Eppendorf (UKE) in Hamburg initiates Phase II trial to evaluate precision medicine approach with Adrecizumab to treat hospitalized patients with moderate to severe COVID-19
Hennigsdorf/Berlin (Germany), April 11, 2022 – Adrenomed AG, the vascular integrity company, today announced that its proprietary sepsis drug candidate Adrecizumab (HAM8101) received a funding commitment of € 7.4 million from the German Federal Ministry of Education and Research (BMBF) as part of the German funding initiatives for the clinical development of COVID-19 drugs and their manufacturing capabilities.[1],[2] The University Medical Center Eppendorf (UKE) Hamburg and Adrenomed will receive funds to conduct an investigator initiated Phase II clinical trial with Adrecizumab in hospitalized patients with moderate to severe COVID-19, which has received regulatory approval by the German federal agency, Paul Ehrlich Institute (PEI). Additionally, the BMBF will support financially the manufacturing of GMP Phase III clinical trial material.
Adrecizumab, a first-in-class antibody targeting the vasoprotective peptide adrenomedullin, is currently being developed for the treatment of loss of vascular integrity in sepsis and septic shock. Dysregulation of the endothelial barrier appears to be a common feature of COVID-19 patients and sepsis or septic shock patients. The deteriorated endothelial barrier function leads to vascular leakage and severe impairment of lung and other organ functions. In a novel precision medicine approach, patients with elevated adrenomedullin levels will be treated with Adrecizumab to restore and maintain the endothelial barrier and to avoid further organ dysfunction. At the same time, another biomarker (dipeptidyl peptidase-3, DPP3) is used to exclude patients with an additional competing pathophysiology. The UKE has initiated a national, multicenter, biomarker-guided, placebo-controlled Phase II trial to evaluate the efficacy of Adrecizumab plus standard of care (SOC) and plans to enroll more than 200 patients with moderate to severe COVID-19 and elevated adrenomedullin levels.[3]
Prof. Dr. med. Stefan Kluge, Director of the Department of Intensive Care Medicine at UKE, said: “We urgently need effective drugs for the treatment of hospitalized COVID-19 patients. Particularly important are therapies that can be used in severe cases and can be given at later disease stages. Adrecizumab could potentially be a therapy that can address this treatment gap. In a previous named-patient program with critically ill COVID-19 patients treated with Adrecizumab, we have already observed a rapid improvement in organ function. Based on these results and the positive signals from the AdrenOSS-2 study in septic shock, we will now evaluate a precision medicine approach with Adrecizumab to treat COVID-19 patients with deteriorating endothelial function and increased risk of organ failure and mortality.”
“With Adrecizumab we provide a treatment option that aims at restoring and maintaining the impaired vascular integrity in COVID-19 other than antiviral drugs”, Dr. Jens Zimmermann, Chief Medical Officer at Adrenomed added. “This approach may help to improve the organ function and thus survival rates of hospitalized COVID-19 patients. We are very grateful for this financial support granted by the BMBF which enables Adrenomed to pursue the clinical development of Adrecizumab in the treatment of COVID-19, as well as the manufacturing process.”
Dr. Richard Jones, Chief Executive Officer of Adrenomed, stated: “This funding commitment of € 7.4 million from the BMBF is a significant endorsement of Adrenomed’s innovative bio-marker guided precision medicine approach for patients in the acute care setting. This clinical study further compliments our overall development program of Adrecizumab for the treatment of loss of vascular integrity in sepsis and septic shock in collaboration with our strategic partner, Sphingotec.”
About Adrenomed
Adrenomed AG is a German privately financed, clinical-stage biopharmaceutical company. Adrenomed’s mission is to rescue vascular integrity and save the lives of critically ill patients with limited treatment options. Founded in 2009 by a management team with decades of in-depth experience in sepsis and deep knowledge in diagnostics and drug development, the company’s lead product candidate Adrecizumab (INN: enibarcimab) is a first-in-class monoclonal antibody. Adrecizumab targets the vasoprotective peptide Adrenomedullin, an essential regulator of vascular integrity. Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock. For further information, please visit www.adrenomed.com and follow us on LinkedIn and Twitter.
Contact
Adrenomed AG
Frauke Hein, Ph.D. (Chief Business Officer)
phone: +49 (0)3302 2077814
Media Inquiries
MC Services AG
Eva Bauer / Julia von Hummel
phone: +49 (0)89 21022880
[1] https://www.gesundheitsforschung-bmbf.de/de/12638.php
[2] https://www.gesundheitsforschung-bmbf.de/de/13173.php
[3] https://clinicaltrials.gov/ct2/show/NCT05156671?term=adrecizumab&draw=2&rank=4
ONWARD Medical’s Parkinson’s Therapy Published in New England Journal of Medicine
ONWARD Medical’s Parkinson’s Therapy Published in New England Journal of Medicine
EINDHOVEN, the Netherlands & LAUSANNE, Switzerland—April 7, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announces an important publication in the New England Journal of Medicine (NEJM), highlighting the use of ONWARD’s innovative approach to treating orthostatic hypotension in a patient with MSA-P, a degenerative nervous system disease.
EINDHOVEN, the Netherlands & LAUSANNE, Switzerland—April 7, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announces an important publication in the New England Journal of Medicine (NEJM), highlighting the use of ONWARD’s innovative approach to treating orthostatic hypotension in a patient with MSA-P, a degenerative nervous system disease.
eGenesis Appoints Eliezer Katz, M.D., FACS, as Chief Medical Officer
eGenesis Appoints Eliezer Katz, M.D., FACS, as Chief Medical Officer
eGenesis Appoints Eliezer Katz, M.D., FACS, as Chief Medical Officer
CAMBRIDGE, Mass., April 04, 2022 – eGenesis, a gene-editing and genome-engineering company developing human-compatible organs and cells, today announced the appointment of Eliezer Katz, M.D., FACS, as Chief Medical Officer (CMO).
“We believe Dr. Katz is an ideal fit for eGenesis because of both his clinical experience as a transplant surgeon and his successful career in the pharmaceutical industry, leading the development of therapeutics in transplant and immunology,” said Paul Sekhri, President and Chief Executive Officer of eGenesis. “His knowledge and expertise have the potential to help us accelerate our progress into clinical trials for our human-compatible organs and cells.”
Dr. Katz is an experienced transplant surgeon and a leader of clinical development in the pharmaceutical industry. He oversaw the development of therapeutics to modulate the immune system in autoimmune diseases and organ transplantation. Most recently, he was Vice President, Clinical Development at Horizon Therapeutics following its acquisition of Viela Bio, Inc. At Horizon and Viela, Dr. Katz led the clinical development of inebilizumab, including the regulatory submission and approval of UPLIZNA® (inebilizumab) to treat neuromyelitis optica spectrum disorder in adults.
Prior to his tenure at Viela and Horizon, Dr. Katz served as Senior Director of Clinical Development at MedImmune Inc. where he oversaw the clinical development of three different biologics. Before that, Dr. Katz served as the Senior Director of Transplantation with the Medicine Development Group at Pfizer, Inc. At Pfizer, he worked across business divisions to oversee multiple research programs with rapamycin, an anti-rejection drug, strengthening his relationships with the medical and surgical transplant community, and conducting key advisory boards. Dr. Katz participated in the planning of Phase 3 clinical trials for tofacitinib, a JAK3 inhibitor and a novel immunosuppressive drug. He was instrumental in the regulatory submission and FDA approval in 2015 of rapamycin as a treatment for lymphangioleiomyomatosis (LAM), a rare and fatal lung disease.
Dr. Katz’s first position in the pharmaceutical industry was at CTI Clinical Trial and Consulting Services where he served as the VP of Medical Affairs and supported all stages of drug development and clinical trials in transplantation, immunology, and other related areas.
Before joining industry, Dr. Katz had an almost two-decade career as a transplant surgeon, including the directorship of two transplantation programs. He was director of the abdominal transplantation division at Integris Baptist Medical Center in Oklahoma City, and an associate professor of surgery and the director of the liver transplantation division at the University of Massachusetts Medical Center, Worcester, MA. In both positions Dr. Katz implemented techniques related to liver transplantation and was actively involved with policy making in organ donation and allocation.
Dr. Katz earned his M.D. at Hadassah Hebrew University Medical School in Jerusalem. “As a transplant surgeon and drug developer, I have seen the huge impact that organ transplantation can have on patients’ lives,” said Dr. Katz. “However, I have also seen the despair of patients who would benefit from a transplant but are unable to access the life-saving surgery due to the significant shortage of available organs. eGenesis’ human compatible organ and cell platform has the potential to address this shortage and radically improve how we treat organ failure. I look forward to working with the eGenesis team to make this mission a reality.”
About Transplantation and Xenotransplantation
The demand for lifesaving organs far outnumbers available supply. In the U.S. alone, more than 100,000 people are on the national transplant list. Twenty people die every day due to lack of available organs for transplant and every 10 minutes, a new name is added to the national transplant waitlist.
The concept of xenotransplantation (the transplantation of organs and cells from one species to another) has been explored for decades, with the pig considered the most suitable donor for humans. However, virology and immunology hurdles prevented the field from advancing beyond early preclinical research. With the advent of cutting-edge gene editing technologies, addressing these historical challenges is now within reach.
About eGenesis
eGenesis’ goal is to transform the field of transplantation by offering safe and effective organs and cells to patients in need. The company harnesses gene editing technology including CRISPR to address the key issues that have impeded xenotransplantation to date. eGenesis’ development pipeline includes lead programs for kidney and islet cell transplant as well as earlier-stage programs focused on other solid organs. Learn more at egenesisbio.com.
Contacts:
Investors/Media
David Carmel
eGenesis, Inc.
212-213-0006
Investors
Eric Ando / Dr. Grace Kim
Burns McClellan, Inc.
212-213-0006
/
Media
Robert Flamm, Ph.D. / Katie Larch
Burns McClellan, Inc.
212-213-0006 ext. 364
/