Piper Jaffray analyst Christopher Raymond noted that Amag Pharmaceuticals announced it has taken over development of digoxin immune Fab for the treatment of severe preeclampsia from Velo Bio and seeks to add an additional 174 patients by the end of 2019, which he believes “may be a tall order.” As he waits to see how enrollment progresses for this trial, he continues to have concerns with Amag’s current franchise as Makena, which makes up over 70% of revenue, recently began facing generic competition, Raymond tells investors. The analyst maintains a Neutral rating on Amag shares and says he is still “comfortable on the sidelines.”
Wednesday, September 26, 2018
Alphatec Wins OsseoScrew® FDA Clearance
Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its OsseoScrew® System, making it available for clinical use for the first time in the United States.
“I am exceptionally pleased that OsseoScrew has been cleared for the U.S. market,” said Pat Miles, Chairman and Chief Executive Officer. “The system will create new market opportunities for ATEC by uniquely addressing an unmet need for an underserved patient population. We are building an organic innovation machine and today’s announcement represents another significant step toward creating a clinically distinguished portfolio.”
Carpenter to Retire as Chair, CEO of LifePoint; President, COO Dill to CEO
LifePoint Health (NASDAQ: LPNT) and its Board of Directors announced today that current Chairman and Chief Executive Officer (CEO) William F. Carpenter III (Bill) will retire upon completion of the Company’s pending merger with RCCH HealthCare Partners, which is anticipated to occur later this year. Following his retirement, Carpenter will join the merged organization’s Board of Directors. David Dill, the Company’s current president and chief operating officer (COO), will assume the role of CEO for LifePoint upon Carpenter’s retirement.
Carpenter has served as CEO since 2006 and was appointed the additional position as chairman of the Board in 2010. He is a founding employee of LifePoint, which was established in 1999. Carpenter led the strategic process that resulted in the transaction that will merge LifePoint with RCCH HealthCare Partners and transition LifePoint to a privately-held company.
“It has been an absolute privilege to lead LifePoint for nearly 13 years, and to be a part of the team since the company’s inception almost 20 years ago. I am incredibly proud of all the organization has accomplished during that time,” said Carpenter. “We’ve grown from 23 hospitals in 9 states, to nearly 70 hospitals in 22 states today, to a footprint that will soon span coast to coast, pending completion of our merger with RCCH HealthCare Partners. We’ve forged partnerships and innovations within the industry that were first of their kind, such as being the only investor-owned system selected by CMS to participate in the Partnership for Patients initiative as a Hospital Engagement Network, and our joint venture partnership with Duke University Health System, Duke LifePoint Healthcare. With David’s leadership, I’m confident that LifePoint will continue to advance its mission of Making Communities Healthier in even more remarkable ways. I cannot think of a better leader to take LifePoint into the future and am pleased to have the opportunity to stay engaged through my participation on the Board.”
Dill joined LifePoint as executive vice president and chief financial officer in 2007. He was named COO in 2009 and appointed president and COO in 2011. Under Dill’s leadership, the Company grew its revenues from $2.6 billion in 2007 to more than $6 billion projected for 2018 and enhanced quality and patient safety across its hospitals, most notably by launching the Company’s National Quality Program in collaboration with Duke University Health System.
“It is a tremendous honor to be named CEO of LifePoint Health. When I joined this organization more than 10 years ago, I was attracted to the mission – Making Communities Healthier. Today, I continue to be energized by our mission and the potential to make a positive impact in communities across the country. I thank and commend Bill for his years of leadership,” remarked Dill. “I believe that LifePoint is better positioned than ever to be the leader in non-urban healthcare, and to help define what the delivery of community-based healthcare looks like in the future. I am fortunate to be surrounded by one of the most talented teams in the industry that will help take us there. Additionally, I am excited about the opportunity to work with the team at RCCH HealthCare Partners as we embark on the next chapter for the combined company.”
Dill will be the first CEO of the merged LifePoint and RCCH HealthCare organization, which will operate under the LifePoint Health name. Following the close of the transaction, LifePoint will operate a diversified portfolio of healthcare assets, including approximately 85 non-urban hospitals in 30 states, regional health systems, physician practices, outpatient centers and post-acute service providers, with leading market positions as the sole community healthcare provider in the majority of the regions it serves.
SeaSpine Announces Launch of Regatta™ Lateral System
SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the launch of the Regatta™ Lateral System, featuring NanoMetalene® technology.
Regatta is a comprehensive, minimally invasive lateral interbody fusion system designed to efficiently and reproducibly treat the spine through indirect decompression and the restoration of sagittal alignment. Regatta offers a wide variety of implants to accommodate the patient’s anatomy, including 10 and 15 degree lordotic options for sagittal alignment and 18 and 23mm wide implants for complete endplate coverage. The Regatta lateral retractor and the EMG nerve detection dilators allow for customizable access with minimal tissue disruption through the psoas, while also providing the visualization necessary to effectively perform the procedure. The addition of new streamlined disc preparation and angled instruments to access challenging disc spaces combine to deliver the complete procedural solution.
“We are excited to provide this comprehensive lateral system to surgeons who perform less-invasive interbody fusion procedures that minimize the tissue disruption that typically accompanies traditional spinal fusion surgery. By optimizing each procedural element, from access to fusion, the surgeon can efficiently and effectively treat each patient’s unique spinal condition,” said Keith Valentine, President and Chief Executive Officer.
The Regatta interbody devices feature proprietary NanoMetalene surface technology. NanoMetalene is a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition. It is designed to provide implants a bone-friendly titanium surface on endplates and throughout graft apertures, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging.
“The Regatta system offers a variety of sizes and angles of interbody implants to address the majority of patient anatomy requirements and my surgical correction goals. Additionally, the implant’s novel NanoMetalene titanium surface technology may allow for more rapid and reliable fusion healing, and allows me to consider a wider variety of graft materials, potentially reducing the cost of care,” stated Dr. James Bruffey, Orthopedic Spine Surgeon, Scripps Health – San Diego, CA.
SeaSpine will be conducting initial cases through a limited launch over the coming months and expects a full commercial launch of the Regatta Lateral System in the first half of 2019.
VIVO Cannabis: Canna Farms Completes First Shipment of Recreational Cannabis
VIVO Cannabis Inc. (TSX-V: VIVO, OTCQB: VVCIF) (VIVO or the Company) is pleased to announce that its wholly-owned subsidiary, Canna Farms Ltd.(Canna Farms) has fulfilled and shipped its first recreational cannabis purchase destined for the British Columbia Liquor Distribution Branchs (BCLDB) warehouse.
Dan Laflamme, President of Canna Farms, said, It was satisfying for Canna Farms to ship this first, historic shipment of recreational cannabis. We fulfilled the BCLDBs purchase order on time and in accordance with our plans and processes. We look forward to making similar shipments in the next few weeks to Yukon, Alberta, Saskatchewan, Manitoba, and Ontario from our production facilities in Hope, British Columbia. The world is watching Canada as we lead the way globally in creating a federally regulated adult-use cannabis market.
Electromed up 18% on FQ4 earnings
Thinly traded nano cap Electromed (ELMD +17.6%) is up on a healthy 35x surge in volume, albeit on turnover of only 472K shares, in response to its fiscal Q4 results released after yesterday’s close.
Revenue was up 13% to $8.2M and net income jumped 18% to $1.1M. Cash flow ops was up 48% to $570K.
Aldeyra: Positive Results from Phase 2b Dry Eye Disease Clinical Trial
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced positive results from its Phase 2b clinical trial of topical ocular reproxalap in patients with dry eye disease.
“The early onset and broad activity observed in the Phase 2b clinical trial suggests that reproxalap could be an important treatment option relative to existing therapies,” commented John Sheppard, M.D., Professor of Ophthalmology, Eastern Virginia Medical School. “The results announced today confirm the potential of reproxalap, a drug with a novel mechanism of action, as a promising and differentiated therapeutic agent for dry eye disease, which remains a persistently challenging condition for large numbers of patients worldwide.”
The randomized, vehicle-controlled, parallel-group, multi-center, double-masked Phase 2b clinical trial investigated 0.1% and 0.25% concentrations of reproxalap topical ophthalmic solution versus vehicle. Relative to patients treated with vehicle, patients treated with the 0.25% concentration of reproxalap had statistically significant and clinically relevant reductions in the Four-Symptom Ocular Dryness Score (p<0.05) and the Overall Ocular Discomfort Symptom Score (p<0.05). Symptom improvement greater than that of vehicle was consistently observed across all measures, and activity versus vehicle was demonstrated as early as two weeks (the first assessment following initiation of therapy). The early onset of symptomatic improvement is consistent with the Phase 2a clinical trial of topical ocular reproxalap in dry eye disease, and is supportive of a differentiated product profile relative to current standard of care. Patients treated with the 0.25% concentration of reproxalap also demonstrated reductions in ocular fluorescein staining score that were statistically superior to those of patients treated with vehicle (p<0.05).
Both 0.1% and 0.25% reproxalap concentrations demonstrated activity relative to vehicle, and a clear dose response was observed. Consistent with previous clinical trials, topical ocular reproxalap was well tolerated, and reported adverse events were generally mild.
Three hundred patients with dry eye disease were randomized equally to receive 0.1%, 0.25%, or vehicle for 12 weeks. The primary objective of the trial was to evaluate the safety and efficacy of reproxalap for the treatment of the symptoms and signs of dry eye disease in order to select a drug concentration, confirm endpoint selection, and determine sample size for a pivotal Phase 3 clinical program.
“Based on the successful Phase 2b results, we look forward to initiating a Phase 3 program in dry eye disease in 2019 following our discussion with regulatory authorities,” commented Todd C. Brady, M.D., Ph.D., Chief Executive Officer of Aldeyra. “The addition of dry eye disease to our late-stage clinical portfolio, which includes Phase 3 clinical trials in allergic conjunctivitis and noninfectious anterior uveitis, highlights the potential of reproxalap as a highly differentiated and novel ophthalmic therapy.”
Conference Call
Aldeyra will hold a conference call on September 26, 2018 at 8:00 a.m. ET to discuss results of the clinical trial. The dial-in numbers are 1-877-266-8979 for domestic callers and 1-412-317-5231 for international callers. A live webcast of the conference call will also be available on the investor relations page of Aldeyra’s corporate website at ir.aldeyra.com. After the live webcast, the event will remain archived on Aldeyra’s website for one year.
Aldeyra will hold a conference call on September 26, 2018 at 8:00 a.m. ET to discuss results of the clinical trial. The dial-in numbers are 1-877-266-8979 for domestic callers and 1-412-317-5231 for international callers. A live webcast of the conference call will also be available on the investor relations page of Aldeyra’s corporate website at ir.aldeyra.com. After the live webcast, the event will remain archived on Aldeyra’s website for one year.
Subscribe to:
Posts (Atom)