Jan Pensaert

Magenta is developing miniaturized catheter-mounted axial flow-pumps for mechanical circulatory support indications, based on Magenta’s core technology of self-expanding impellers and pump heads. Our percutaneous Left Ventricular Assist Device (pLVAD) is a next-generation low-profile arterial pump, intended for temporary support of patients undergoing high-risk coronary interventions and the treatment of patients admitted with cardiogenic shock.

Founded in 2008, NeoSync, Inc. is a clinical stage company that is pioneering personalized transcranial magnetic stimulation for the treatment of Major Depressive Disorder and other diseases of the Central Nervous System (CNS). The company is well-positioned to unlock the enormous potential of an existing but still nascent market (TMS for treatment-resistant depression), with a disruptive home use design. Over 27MM adults globally (16MM in US) suffer from depression each year. Pharmacological therapy is the current mainstay treatment for major depression, with over 300MM scripts written per year in the US alone, but large studies have shown that only 30% of depressed patients respond to leading antidepressants (STAR*D). Antidepressants also have significant side effects, including dizziness, anxiety, insomnia, sexual dysfunction, fatigue, restlessness, and fibromyalgia. Non-pharmacological options like Electroconvulsive Therapy (ECT) are considered more effective, but reserved for the most severe cases (100k/year) because of the need for sedation and serious side effects (memory loss and confusion). NEST® (NeoSync-EEG Synchronized TMS) delivers low energy, alternating magnetic field stimulation in daily 30 minute sessions to gently adjust a depressed patient’s brain toward a more normal state. Unique among TMS therapies, NEST® is personalized to a patient’s unique alpha frequency, as measured by the electroencephalogram (EEG). In follow up to a successful 45 patient pilot study, NeoSync conducted a 200 patient randomized, multi-center, sham-controlled clinical trial with investigators from 17 leading academic and private psychiatry sites. The results for treatment-resistant depression patients as intended compared favorably to the results seen from prior TMS clinical studies in comparable patient populations. In addition, the NeoSync NEST® shows a superior safety and tolerability profile relative to literature on other existing therapies, with no device-related major adverse events. NeoSync is currently conducting a clinical study to support its planned 510K submission to seek FDA clearance of the NEST® device for home use.

4TECH Inc. is dedicated to improving patients'​ quality of life by treating tricuspid regurgitation with a simple transcatheter solution.

JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis. In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR. JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.

JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis. In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR. JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.

This page is intended for US audiences. At Pacira Biosciences, Inc., we are driving innovation to provide ways to manage pain safely and effectively. iovera° is a patented, 510(k)-cleared medical device, which uses targeted cryoanalgesia for immediate and long-lasting pain relief. iovera° treats peripheral nerves to temporarily stop pain signals for up to 90 days and provides pain relief until the nerve regenerates and nerve signaling is restored through an innovative handheld design. The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue. iovera° should not be used for people with: cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud’s disease, open and/or infected wounds at or near treatment site. Patients treated with iovera° (a needle-based therapy) may have certain reactions, including but not limited to bruising, swelling, inflammation and/or redness, local pain and/or tenderness, altered feeling at application site. Proper iovera° use (see User Guide) can help reduce or prevent these reactions: in treatment area(s) – skin damage from being exposed to cold/heat, skin darkening/lightening, skin dimples; outside treatment area(s) – muscles may not work/move normally. Adverse event reporting: email drugsafety@pacira.com or call 1-855-793-9727. Product quality complaints: email ioveraCS@icsconnect.com or call 1-800-442-0989. Please don't report such information through this or other social media pages owned by Pacira Biosciences, Inc. If you do report through this page, Pacira reserves the right to contact you for information.

MyCartis is an immuno-diagnostic solution provider assuring accurate, clinical guidance with its sample to answer Evalution® platform. MyCartis develops its own immuno-diagnostic menu for the clinical user and collaborates with partners to port assays on its platform. EVALUTION® leverages high quality analytical performance from conventional immunodiagnostic approaches with the unique capability to quantify and monitor binding reactions in real-time. This provides the user with novel, timely and hence highly actionable information. MyCartis primarily focuses on oncology and in particular immuno-oncology. One of the assays in development will monitor adverse events in cancer patients undergoing immuno-oncology treatment. In addition to the existing Evalution® RUO platform, MyCartis is developing a CE-IVD clinical configuration and has obtained its ISO13485 certification. Visit www.mycartis.net or contact MyCartis for more information: info@mycartis.net

Magenta is developing miniaturized catheter-mounted axial flow-pumps for mechanical circulatory support indications, based on Magenta’s core technology of self-expanding impellers and pump heads. Our percutaneous Left Ventricular Assist Device (pLVAD) is a next-generation low-profile arterial pump, intended for temporary support of patients undergoing high-risk coronary interventions and the treatment of patients admitted with cardiogenic shock.

Founded in 2008, NeoSync, Inc. is a clinical stage company that is pioneering personalized transcranial magnetic stimulation for the treatment of Major Depressive Disorder and other diseases of the Central Nervous System (CNS). The company is well-positioned to unlock the enormous potential of an existing but still nascent market (TMS for treatment-resistant depression), with a disruptive home use design. Over 27MM adults globally (16MM in US) suffer from depression each year. Pharmacological therapy is the current mainstay treatment for major depression, with over 300MM scripts written per year in the US alone, but large studies have shown that only 30% of depressed patients respond to leading antidepressants (STAR*D). Antidepressants also have significant side effects, including dizziness, anxiety, insomnia, sexual dysfunction, fatigue, restlessness, and fibromyalgia. Non-pharmacological options like Electroconvulsive Therapy (ECT) are considered more effective, but reserved for the most severe cases (100k/year) because of the need for sedation and serious side effects (memory loss and confusion). NEST® (NeoSync-EEG Synchronized TMS) delivers low energy, alternating magnetic field stimulation in daily 30 minute sessions to gently adjust a depressed patient’s brain toward a more normal state. Unique among TMS therapies, NEST® is personalized to a patient’s unique alpha frequency, as measured by the electroencephalogram (EEG). In follow up to a successful 45 patient pilot study, NeoSync conducted a 200 patient randomized, multi-center, sham-controlled clinical trial with investigators from 17 leading academic and private psychiatry sites. The results for treatment-resistant depression patients as intended compared favorably to the results seen from prior TMS clinical studies in comparable patient populations. In addition, the NeoSync NEST® shows a superior safety and tolerability profile relative to literature on other existing therapies, with no device-related major adverse events. NeoSync is currently conducting a clinical study to support its planned 510K submission to seek FDA clearance of the NEST® device for home use.

4TECH Inc. is dedicated to improving patients'​ quality of life by treating tricuspid regurgitation with a simple transcatheter solution.

JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis. In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR. JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.

JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis. In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR. JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.