|Ascendis Announces Results of Phase 1 Study of TransCon Treprostinil; CryoLife Announces Enrollment in PerClot® IDE Clinical Trial|
|By Josh Gee|
|Tuesday, 28 April 2015 19:11|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 28, 2015.
Ascendis Pharma A/S (NASDAQ: ASND), announced its Phase 1 single ascending dose study of TransCon Treprostinil produced dose-dependent increases in plasma treprostinil levels in-line with expectations. However, treprostinil-related injection-site tolerability issues did not meet the criteria defined in the target product profile. Ascendis now intends to conduct additional research on new product formulations of TransCon Treprostinil and plans to resume clinical development when product improvements to mitigate current limitations have been addressed.
Jan Mikkelsen, Chief Executive Officer of Ascendis, stated "While we are pleased with the pharmacokinetic results observed in this study, and believe they affirm the potential of our TransCon technology, TransCon Treprostinil did not reproduce the tolerability profile observed in preclinical studies." Mr. Mikkelsen continued, "As we look forward to the remainder of 2015, we plan to finalize and report topline data from our Phase 2 pediatric study of TransCon Growth Hormone by mid-year and prepare for the initiation of our Phase 3 pediatric study in mid-2016. We will also continue to develop our internal pipeline of therapeutics for orphan diseases."
CryoLife, Inc. (NYSE: CRY), announced the enrollment of the first patient in its PerClot Investigational Device Exemption (IDE) clinical trial, the Company's pivotal clinical trial to gain approval to commercialize PerClot in the U.S.
"The first patient enrolled in the PerClot IDE clinical trial is a positive milestone for the Company and our strategy to expand indications for our products," stated Pat Mackin, CryoLife Chairman, President, and Chief Executive Officer. "We will be working to bring other trial sites online in the coming months, positioning us to complete enrollment in the trial in the first half of 2016. With a three-month follow-up period, we would anticipate obtaining FDA approval for PerClot in the second half of 2017."
"As surgeons, we are continually confronted with controlling surgical bleeding," stated Arthur Coffey, MD, Cardiac Surgeon and PI for the PerClot IDE at Indiana University Health. "We are excited to have the opportunity to evaluate this innovative technology, using a validated bleeding scale, for its ability to control bleeding during cardiac and general surgery." Michael House, MD, General Surgeon at Indiana University Health commented that "this trial is the first of its kind and represents the future for evaluating hemostatic devices desiring market approval. We are excited to announce enrollment of the first patient into this important clinical trial to evaluate PerClot in the U.S."
The PerClot IDE is a multicenter, multidisciplinary, controlled clinical investigation. The study will include 324 patients across cardiac, general, and urological surgical specialties. The primary objective of this investigation will be to collect clinical data concerning the safety and efficacy of PerClot versus C.R. Bard's Arista™ MPH Hemostat in multiple surgical disciplines when used as an adjunct to conventional means of achieving hemostasis such as pressure or ligature. The primary efficacy endpoint of this investigation will be achievement of hemostasis at the site of application at seven minutes following application of the prescribed hemostatic agent. The secondary efficacy endpoint for this investigation will be hemostasis at the site of application evaluated at five minutes. Safety endpoints will include, but are not limited to, the incidence of reoperation due to bleeding, total hospitalization and procedure time, and the incidence of procedure complications and/or adverse events through final patient follow-up at three months.
Advaxis, Inc. (Nasdaq:ADXS), a cancer immunotherapy company, today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 9,012,141 with composition of matter claims covering the Advaxis product candidate, ADXS-PSA, and U.S. Patent No. 9,017,660 with methods of use claims covering the Advaxis product candidate, ADXS-HER2.
BioCorRx, Inc. (BICX) announces MSNBC segment featuring Brady Granier, COO and interim CEO, alongside Start Fresh Program and Growing Pains alum, Jeremy Miller.
BioSig Technologies (OTCQB: BSGM) executive leadership will be attending the Heart Rhythm Society's 36th Annual Scientific Sessions from May 13 – 16 in Boston, Massachusetts.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today announced that it will report financial results for the first quarter of 2015 on Tuesday, May 5, 2015, prior to the market's opening.
Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced that Joseph J. Sarret, M.D., J.D. has joined the Company in the newly created position of Chief Business Officer. Reporting to Corium's President and Chief Executive Officer, Peter D. Staple,
iKang Healthcare Group, Inc. (Nasdaq:KANG), China's largest private preventive healthcare services provider, today announced that it will attend Morgan Stanley Inaugural China Summit in Beijing at Rosewood Hotel Beijing on May 27 to May 29, 2015.
In a release issued on Thursday, April 23rd, 2015 by K2M Group Holdings, Inc. (Nasdaq:KTWO), the Company announced that Management will host a conference call May 6th to discuss the results of the quarter and to host a question and answer session.
LeMaitre Vascular, Inc. (Nasdaq:LMAT), a provider of vascular devices, today reported Q1 2015 results, announced a $0.04/share dividend and provided guidance.
Lumenis Ltd. (Nasdaq:LMNS), the world's largest energy-based medical company for aesthetic, surgical and ophthalmology applications, today announced plans to release its first quarter of fiscal year 2015 financial results on Tuesday, May 12, 2015, after market close.
Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that it will participate in the upcoming Annual Meeting of The Association for Research in Vision & Ophthalmology (ARVO) from May 3 - 7, 2015 in Denver, Colorado.
MedAssets (Nasdaq:MDAS) today announced that Athens Regional Medical Center (ARMC), the 350-plus bed anchor hospital for Athens Regional Health System, has expanded its engagement with the company in a broad-scale technology initiative designed to optimize revenue cycle operations. ARMC's multi-phased agreement will deploy MedAssets end-to-end portfolio of Revenue Cycle Management (RCM) solutions to upgrade and standardize its technology environment.
Nature's Sunshine Products, Inc. (Nasdaq:NATR), a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today announced that it will report first quarter 2015 financial results for the period ended March 31, 2015, on Thursday, May 7, 2015, at 4:00 p.m. Eastern Time.
Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced financial results for its first quarter ended March 31, 2015.
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize energy to treat cancer, today announced the appointment of Peter Vitulli to the Company's Board of Directors effective April 23, 2015.
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today announced that members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences: Credit Suisse's Antibody Day on Wednesday, May 6, 2015 at 12:05 p.m. EDT in New York, NY; Bank of America Merrill Lynch 2015 Health Care Conference on Wednesday, May 13, 2015 at 1:40 p.m. PDT at Encore at the Wynn in Las Vegas, NV; UBS 2015 Global Healthcare Conference on Monday, May 18, 2015 at 10:00 a.m. EDT at Sheraton Times Square Hotel in New York, NY
Sientra, Inc. (Nasdaq:SIEN), a medical aesthetics company, announced today that the Company will release its first quarter 2015 financial results on Wednesday, May 13, 2015 after the market close.
Surgical Care Affiliates, Inc. (Nasdaq:SCAI) today announced that it will release its first quarter 2015 financial results after U.S. financial markets close on Monday, May 11, 2015. In conjunction with the announcement, SCA will host a conference call at 4:30 p.m. Eastern Time on Monday, May 11, 2015, to discuss its first quarter 2015 financial and operating results.
Vocera Communications, Inc. (NYSE:VCRA), the leading provider of intelligent, real-time communication solutions for healthcare and other mission-critical mobile environments, today announced it will co-host an Innovation Showcase with Rock Health, a seed and early stage venture fund that supports companies building the next generation of healthcare technologies.