Nyxoah announces CE-mark approval to treat Complete Concentric Collapse (CCC) patients
Gilde Healthcare
by Gilde Healthcare
2y ago
Utrecht, The Netherlands & Mont-Saint-Guibert, Belgium - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that DEKRA Notified Body has approved the Company’s proposed indication for the Genio® system to treat patients with a Complete Concentric Collapse (“CCC”). DEKRA attributed the updated Genio® therapeutic indication to the BETTER SLEEP study data presented by the Company, concluding that “the effectiveness r ..read more
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Noema Pharma appoints Jeffrey Jonas as independent Chairman of the Board of Directors
Gilde Healthcare
by Gilde Healthcare
2y ago
Utrecht, The Netherlands & Basel, Switzerland - Noema Pharma, a Swiss-based clinical stage company targeting orphan central nervous system (CNS) diseases, today announces the appointment of Jeffrey Jonas MD as Chairman of the Board of Directors. Dr. Jonas is a neuropsychiatry expert and former Chief Executive Officer of Sage Therapeutics, with more than 25 years of experience in the pharmaceutical and healthcare industries. He takes the reins from Darren Carroll, a partner with Polaris Partners, who will remain a member of the Board of Directors. "I am delighted that Jeff is joining Noema ..read more
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Acacia Pharma announces Marketing Authorization Application for BARHEMSYS® in Europe
Gilde Healthcare
by Gilde Healthcare
2y ago
Utrecht, The Netherlands, Cambridge, UK & Indianapolis, US - Acacia Pharma (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or cancer chemotherapy, announces that its Marketing Authorization Application (MAA) for BARHEMSYS® (amisulpride injection) has been submitted, validated and is now under formal review in major European markets. The review process is expected to be completed by Q3/2022. BARHEMSYS was approved ..read more
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Gilde Healthcare names Robert Stein as Partner in Germany
Gilde Healthcare
by Gilde Healthcare
2y ago
With more than 25 years of Private Equity investment experience in ‘Mittelstand’ companies in the DACH Region and Europe, Robert will join the Private Equity team of Gilde Healthcare and operate out of the local Frankfurt office to further grow the portfolio of investments. Before joining Gilde, Robert worked for 3i, Argantis and founded Arcana Capital, where he sourced, managed and executed investments for large European Family Offices. ‘I am very much looking forward to my new role to further develop the Gilde business out of Frankfurt with a main focus on the DACH region. With a successful ..read more
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Amphista Therapeutics appoints new chairman, Joshua T. Brumm
Gilde Healthcare
by Gilde Healthcare
2y ago
Utrecht, The Netherlands & Glasgow, Scotland - Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced the appointment of Joshua T. Brumm as its new Independent Chairman, succeeding Satish Jindal. Amphista’s CEO Dr Nicola Thompson said, “On behalf of the Amphista team I am thrilled to welcome someone of Josh’s calibre to the Board. I look forward to working with Josh as we rapidly develop our pipeline of TPD therapeutics in oncology and beyond and unlock the full therapeutic potential of this exciting new modality. I would also like ..read more
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Nyxoah announces U.S. FDA breakthrough device designation granted for the Genio® system for obstructive sleep apnea and complete concentric collapse
Gilde Healthcare
by Gilde Healthcare
3y ago
Utrecht (the Netherlands) & Cambridge (Massachusetts - US) - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), announced that the U.S. Food and Drug Administration (FDA) has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate. The FDA’s Breakthrough Designation Pr ..read more
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AM-Pharma signs exclusive license agreement with Kyowa Kirin for commercialization of ilofotase alfa in Japan
Gilde Healthcare
by Gilde Healthcare
3y ago
Utrecht, The Netherlands & Tokyo, Japan - AM-Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, and Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, today announced that they have entered into an exclusive license agreement under which Kyowa Kirin gains the rights to develop and commercialize ilofotase alfa, AM-Pharma’s proprietary recombinant human alkaline phosphatase. Ilofotase alfa is currently being ..read more
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Spire Health closes $38 million financing round led by Gilde Healthcare to advance respiratory remote patient monitoring
Gilde Healthcare
by Gilde Healthcare
3y ago
San Francisco (California, US) & Cambridge (Massachusetts, US) – Spire Health, the leading provider of respiratory remote patient monitoring (RPM), today announced the closing of a $38 million equity financing, led by Gilde Healthcare Partners along with a leading global medtech strategic partner. Geoff Pardo, General Partner at Gilde Healthcare, will join Spire’s Board of Directors. Spire Health was advised by JMP Securities LLC in the transaction. The new capital will enable Spire to expand commercialization of its unique respiratory remote patient monitoring (RPM) platform. This will cr ..read more
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LAVA Therapeutics announces treatment of first patient in Phase 1/2a clinical trial
Gilde Healthcare
by Gilde Healthcare
3y ago
LAVA’s first-in-class gamma-delta bsTCE to be evaluated as a treatment for chronic lymphocytic leukemia, multiple myeloma and acute myeloid leukemia Utrecht (the Netherlands) & Philadelphia (US) – Gilde Healthcare portfolio company LAVA Therapeutics N.V. (Nasdaq: LVTX), a biotechnology company focused on developing bispecific gamma-delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced dosing of the first patient in the company’s Phase 1/2a clinical trial of LAVA-051 in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL), multiple myelo ..read more
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Adcendo appoints Michael Pehl as Chief Executive Officer
Gilde Healthcare
by Gilde Healthcare
3y ago
Utrecht (the Netherlands) & Copenhagen (Denmark) – Gilde Healthcare portfolio company Adcendo, a biotech company developing innovative antibody-drug conjugates (ADCs) for the treatment of underserved cancers, announces today the appointment of Michael Pehl as Chief Executive Officer (CEO). Henrik Stage, co-founder of Adcendo, will move to the role of Chief Financial Officer. Michael Pehl has over 25 years of international biotechnology and oncology leadership experience in both the US and Europe. He joins Adcendo from GEMoaB, where he served as CEO and led the recent formation and launch o ..read more
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