Delcath Receives Value 4 Reimbursement Status For Chemostat; FDA Grants Pre-Market Approval for Medtronic Melody® Transcatheter Pulmonary Valve Print E-mail
By Josh Gee   
Tuesday, 03 February 2015 19:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 3, 2015.
Delcath Systems, Inc. (NASDAQ: DCTH) announces that the Institut für das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, has affirmed Value 4 coverage status for 2015 for the treatment of patients with liver metastases with the Delcath Hepatic CHEMOSAT® Delivery System.

Under the Neue Untersuchungs und Behandlungsmethoden (NUB) reimbursement scheme, Value 4 Status does not mandate reimbursement but does permit cancer centers to negotiate for reimbursement coverage for designated procedures with insurers serving their region.  InEk first established NUB Value 4 status for CHEMOSAT procedures in 2013, and affirmed this assessment for 2014 and 2015.  The NUB is an annual process and participating centers in Germany are required to apply each year for subsequent coverage under the scheme. The InEk determines three status levels for medical procedures submitted for its review: Value 1 (mandated reimbursement), Value 2 (declined for reimbursement), and Value 4 (negotiated reimbursement). The InEk may also decline to make a determination regarding an application.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., Interim President and CEO of Delcath Systems, said, "While we are pleased to have received Value 4 coverage status again in 2015, we continue to expect the primary mechanism for reimbursement to be Individual Funding Requests (IFRs), or case-by-case appeals for reimbursement made to a patient's insurance carrier. While each IFR is evaluated independently, the majority of applications for CHEMOSAT procedures were approved in 2014, and included coverage from a range of sickness funds across a number of regions in Germany. In 2015, we expect that patients in Germany will continue to have access to treatment with CHEMOSAT via the IFR reimbursement mechanism."


Medtronic plc (NYSE: MDT)
, today announced that its Melody® Transcatheter Pulmonary Valve (TPV) received Pre-Market Approval (PMA) from the United States Food and Drug Administration (FDA) based on strong clinical evidence from three clinical studies demonstrating the valve's effectiveness in delaying open-heart reoperation.

The first transcatheter heart valve available anywhere in the world, the Melody TPV was originally approved in 2010 under a Humanitarian Device Exemption (HDE), a regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year. HDEs are granted for medical devices that have demonstrated reasonable safety and probable benefit, but do not have evidence of clinical effectiveness. PMA approval has been issued based on the robust evidence now available that supports both safety and effectiveness of the Melody TPV.

Melody TPV is a minimally invasive therapy shown to effectively prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract (RVOT) conduit caused by congenital heart disease (CHD). More than 7,300 patients worldwide have received the therapy to date, more than half of whom are children with CHD.

"The Melody valve has been a reliable option for patients suffering from CHD, and these data reinforce its strong performance since it was first introduced," said William E. Hellenbrand, M.D., chief of pediatric cardiology at the Yale School of Medicine. "This approval underscores the valve's importance in treating this small patient population, who over their lifetime will face several open heart surgeries."

The PMA approval is based on accumulated data from three clinical studies that followed a total of 310 patients implanted with Melody TPV - the Melody U.S. IDE Study, the Melody U.S. Post Approval Study (PAS) and the Melody European and Canadian Post-Market Surveillance Study (PMSS). Data showed strong valve performance in all three studies in patients implanted with the Melody valve as approximately 98 percent of patients were free from conduit reoperation (open-heart surgery) at one year post-implant. Additionally, 91 percent of patients in the IDE cohort were free from conduit reoperation at five years post-implant.

"The transition from HDE to PMA is an important regulatory milestone, which truly emphasizes the significant clinical benefit that the Melody TPV can bring to people with CHD by providing a therapy option that may reduce the number of open heart surgeries they need throughout their lifetime," said Rhonda Robb, vice president and general manager of Heart Valve Therapies at Medtronic. "Today's approval reinforces Medtronic's ongoing commitment to a congenital heart disease program by providing innovative and successful therapies to this underserved patient group."

CHD is the most common birth defect in the United States; it affects an estimated 40,000 U.S. babies each year.1,2,3 Approximately 20 percent of those infants have deformities that disrupt the blood flow from their RVOT to the pulmonary arteries.4 A subset of these children will receive a connecting conduit early in life to improve that blood flow. If a patient's RVOT conduit fails later in life but is still of adequate size to address the patient's needs (i.e., the patient has not outgrown the conduit), then a Melody TPV may be implanted to help delay a surgical pulmonic valve replacement, which is a much more invasive procedure than transcatheter valve replacement.

 In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.  

Also Tuesday:


Amarantus BioScience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on developing diagnostics in neurology, and therapeutic products with the potential for orphan drug designation in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that it will be presenting at the 17th Annual BIO CEO & Investor Conference being held February 9-10, 2015, at the Waldorf Astoria in New York, New York.

Apricus Biosciences, Inc. (Nasdaq:APRI),
a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that Richard Pascoe, Chief Executive Officer, will present at the 17th Annual BIO CEO & Investor Conference on Monday, February 9th, 2015, at 2:30 p.m. Eastern Time.

Athersys, Inc. (Nasdaq:ATHX)
announced today that it will present at the 17th annual BIO CEO & Investor Conference to be held on February 9-10, 2015 in New York, NY, at The Waldorf Astoria New York.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced that it has purchased webOMR, the web-based clinical applications and electronic health record (EHR) platform developed by Beth Israel Deaconess Medical Center (BIDMC) in Boston.

Authentidate Holding Corp. (Nasdaq:ADAT)
, a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced that Pocono Medical Center of Pennsylvania selected Authentidate's InscrybeMD® telehealth solution to extend clinical care to their patients.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
today announced that Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, February 25, at 4:30pm ET to discuss fourth quarter and full-year 2014 financial results and provide a general business update.

CareDx, Inc. (Nasdaq:CDNA)
, a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non‐invasive surveillance solutions for transplant recipients, today announced that it has entered into a secured credit facility for an aggregate $20 million, issuable in two tranches, with East West Bank.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
today announced that Chief Executive Officer Bob Palay is scheduled to present at the Leerink Global Healthcare Conference held February 11-12, 2015, in New York City.

CNS Response, Inc. (OTCQB:CNSO)
applauds the 114th Congress for passing the Clay Hunt Suicide Prevention for American Veterans Act today.

Corium International, Inc. (Nasdaq:CORI)
today announced that it will report financial results for the First Quarter Fiscal 2015 on Tuesday, February 10, 2015 after the close of the U.S. financial markets.

CytoDyn Inc. (OTCQB:CYDY)
, a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced that it had concluded its Phase 2b treatment substitution study and reported 39 patients out of 40 participating in the study passed 4 weeks of monotherapy with PRO 140.

DBV Technologies, (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT)
, a clinical-stage specialty biopharmaceutical company, today announced that six abstracts on Epicutanous Immunotherapy (EPIT®) were selected for presentation at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, Texas, February 20-24, 2015.

Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today that the Australian Patent Office has issued a favorable response to the Company's request for re-examination of Neptune Technologies & Bioressources' patent as it relates to krill oil in Australia.

Entellus Medical, Inc. (Nasdaq:ENTL)
, a medical technology company focused on products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, announced today the closing of its initial public offering of 5,294,117 shares of its common stock (including 690,537 shares purchased by the underwriters pursuant to an option to purchase additional shares) at a public offering price of $17.00 per share, resulting in gross proceeds of approximately $90.0 million before underwriting discounts and commissions.

GeneNews Limited (TSX:GEN)
today a provided a progress update on its U.S. joint venture, Innovative Diagnostic Laboratory LLP.

Herborium® Group, Inc.(OTC Pink: HBRM)
, a Botanical Therapeutics® Company and provider of unique, all botanical medicines (Botanical Therapeutics®), announced today that its unique all herbal acne treatment, AcnEase®, will be featured in an editorial in the UK's most popular health focused publication, AT HOME MAGAZINE's Ask the Doctor with Dr. Christian Jessen on February 4th, 2015.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced it has completed the submission of a Premarket Approval (PMA) Supplement application to the United States Food and Drug Administration (the "FDA") for a new Indication of Use of its Integra ® Dermal Regeneration Template for the treatment of diabetic foot ulcers.

K2M Group Holdings, Inc. (Nasdaq:KTWO)
, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced the pricing of a follow-on offering of 6,044,990 shares of its common stock at a price of $18.75 per share.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that it will host a conference call and live audio webcast on Thursday, February 5, 2015 at 10:00 a.m. Eastern Time to discuss financial results for the second quarter of fiscal year 2015, and review key clinical developments and future planned activities.

MedAssets (Nasdaq:MDAS)
today announced that Lakeland Regional Medical Center (LRMC), an 850-bed health system headquartered in Lakeland, Fla., has signed a multi-year agreement in pursuit of enhanced cost savings.

MediciNova, Inc. (Nasdaq:MNOV)
and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of NASH (nonalcoholic steatohepatitis).

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced financial results for its fiscal second-quarter and six months ended December 31, 2014, provided an update on recent business highlights, provided fiscal Q3 financial guidance and revised its financial guidance for the fiscal year ending June 30, 2015.      

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced that Peter D. Meldrum, president and chief executive officer, has notified the company of his decision to retire at the conclusion of the fiscal year on June 30, 2015.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
, announces that on February 2, 2015 Mr. Jim Hamilton officially started as Neptune's President and CEO.

Pacific Biosciences of California, Inc. (Nasdaq:PACB)
today reported an 85% increase in revenue to $16.9 million for the fourth quarter ended December 31, 2014, compared to $9.1 million for the fourth quarter of 2013.

Radius Health, Inc. (Nasdaq:RDUS)
announced today that President and CEO, Robert Ward, will be presenting a company overview at the 17th Annual BIO CEO & Investor Conference on Monday, February 9th, 2015 at 5:00 p.m. Eastern Time at the Waldorf Astoria in New York City

T2 Biosystems, Inc. (Nasdaq:TTOO)
a company developing innovative diagnostic products to improve patient health today announced that the company has entered into a multi-year, strategic agreement with Canon U.S. Life Sciences, Inc. to jointly develop a novel diagnostic test panel to rapidly detect Lyme disease, a tick-borne bacterial infection that, if left untreated, can cause chronic joint inflammation, neurological disorders and cognitive defects.

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that it has commenced an underwritten public offering of up to $125,000,000 of shares of its common stock.

Vascular Solutions, Inc. (Nasdaq:VASC)
today reported financial results for the fourth quarter and full year ended December 31, 2014, and provided financial guidance for the first quarter and full year of 2015.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced that it has priced its previously announced underwritten public offering of common stock consisting of 10,000,000 shares at a public offering price of $8.75 per share.

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