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.

https://www.marketscreener.com/SEASPINE-HOLDINGS-CORP-22497349/news/SeaSpine-Announces-Launch-of-Regatta-trade-Lateral-System-27321266/

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.

https://www.marketscreener.com/VIVO-CANNABIS-INC-45228876/news/VIVO-Cannabis-Canna-Farms-Completes-First-Shipment-of-Recreational-Cannabis-27323179/

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.

https://seekingalpha.com/news/3393114-electromed-18-percent-fq4-earnings

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.

https://www.biospace.com/article/releases/aldeyra-therapeutics-announces-positive-results-from-phase-2b-dry-eye-disease-clinical-trial/

Baxter Gets FDA OK on Bioactive Bone Graft in Posterolateral Spine Surgery

 Baxter International, Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced U.S. Food and Drug Administration (FDA) clearance of ALTAPORE Bioactive Bone Graft, a next-generation bioactive and osteoconductive bone graft substitute, for use as an autograft extender in posterolateral spinal fusion. ALTAPORE had previously been cleared for use in orthopedic surgical procedures in the extremities and pelvis.

ALTAPORE is designed to enhance bone growth with optimized porosity that promotes earlier vascularization, which plays a central role in the bone formation process by providing oxygen, nutrients, and growth factors critical for bone development. ALTAPORE’s porosity also increases cellular activity by providing more surface area for cells to travel along the surface of the graft, which promotes new bone formation. Additionally, ALTAPORE’s unique chemistry contains 0.8 percent silicon by weight, which was shown to be optimal for bone formation in preclinical studies.

“ALTAPORE utilizes Baxter’s proprietary silicate-substituted technology and has an enhanced porosity that provides for earlier vascularization, increased cellular activity and improved volume of new bone growth. I’ve had a good experience with ACTIFUSE bone graft substitute, and am looking forward to taking advantage of the novel characteristics of ALTAPORE for my patients,” said Roger Härtl, M.D., professor of Neurological Surgery, director of Spinal Surgery, and director of the Weill Cornell Medicine Center for Comprehensive Spine Care in New York.

ALTAPORE has been formulated to meet surgeons’ needs, as it is easy to store, handle and implant. Its precise handling characteristics allow the putty to be molded into multiple shapes to adapt to various surgical needs. Additionally, in a pre-clinical posterolateral spinal fusion model, ALTAPORE used as an autograft extender exhibited similar fusion rates to iliac crest autograft, which is considered the current standard of care in spine surgical techniques. The iliac crest is an area of the pelvis commonly used for acquiring autogenous bone graft.

“Providing surgeons with versatile tools like ALTAPORE is critical to our commitment to partner with clinicians to advance healing in the operating room,” said Wil Boren, president of Baxter’s Advanced Surgery business. “With this clearance, more surgeons will have access to this innovative bone graft substitute as we look to improve outcomes across our entire portfolio of surgical products.”

ALTAPORE Bioactive Bone Graft is the latest addition to Baxter’s growing osteobiologics portfolio of surgical products, which includes Actifuse Shape, Actifuse MIS, Actifuse ABX and Actifuse Flow. Baxter received 510(k) clearance for the use of ALTAPORE as an autograft extender in posterolateral spine in August 2018. The company has started the process of packaging inventories carrying the new FDA-approved labeling and expects to start selling product in the United States by year-end. Baxter intends to unveil ALTAPORE at the 2018 North American Spine Society annual congress Sept. 26-29 in Los Angeles.

https://www.biospace.com/article/releases/baxter-announces-u-s-fda-clearance-of-altapore-bioactive-bone-graft-in-posterolateral-spine-surgery/

Is NASH Really a $35 Billion Opportunity?

Is NASH Really a $35 Billion Opportunity? And could it be the middle of the pack that wins the prize?

For the last few years, investors have been talking up the huge potential of drugs to treat nonalcoholic steatohepatitis, also known as NASH. An outgrowth of the obesity epidemic in western countries and elsewhere around the globe, NASH is a form of fatty liver disease. It causes scarring and inflammation and is estimated to affect over 16 million people in the U.S. alone.

Meanwhile, nonalcoholic fatty liver disease (NAFLD), a precursor condition marked by high fat content in the liver, may affect some 80 million people in the U.S. Neither NASH nor NAFLD have any current treatment, and can eventually advance to serious fibrosis, and then to full-blown cirrhosis or cancer. In fact, now that the public health impact of hepatitis C has started to recede, NASH is taking over as the leading cause of liver cancer and transplant. It’s the rare case of a disease that is both common and widespread yet has no pharmacologic options. No surprise that a lot of companies are going after it with a vengeance.

This month, Viking Therapeutics just raised its profile in the race, announcing positive phase 2 results for VK2809, a thyroid receptor agonist. Notably, VK2809 isn’t going after NASH but the broader category of NAFLD, and it just showed an impressive ability to lower liver fat content in this population—albeit in a small study. That pits it directly against Madrigal Pharmaceuticals, which is further ahead with its own thyroid receptor agonist for NAFLD, called MGL-3196. Viking’s drug appears superior at first glance, although differences in the clinical trials should limit any firm conclusions. Nonetheless, the company wasted no time raising $176 million in a secondary offering.

Neither Viking or Madrigal are likely to catch up to the leaders in the field, namely Intercept Pharmaceuticals and GENFIT. Both of these companies have drugs in phase 3. Intercept’s drug, Ocaliva (Obeticholic acid) is actually already approved to treat primary biliary cholangitis, and has produced some impressive phase 2 results in NASH—but also has some considerable safety issues. Genfit’s elafibranor, A PPAR agonist, is perhaps more controversial, as it advanced to phase 3 on a subgroup analysis from a failed phase 2 study. Nevertheless, these two companies are viewed as the likely winners of the NASH race.

The Great Middle

But what if it is the middle of the pack that comes out ahead? A number of large pharma companies are also involved in the NASH race. Allergan got in through the $1.7 billion acquisition of Tobira Therapeutics and its drug Cenicriviroc, a dual antagonist of C-C chemokine receptor types 2 and 5. Gilead Sciences got selonsertib, an inhibitor of apoptosis signal-regulating kinase 1, through the $1.2 billion acquisition of Nimbus Therapeutics. Both of these are in phase 3. Novo Nordisk has Semaglutide in phase 2. (Shire Pharmaceuticals had volixibat, but this program was quietly halted earlier this summer.)

These companies could actually turn out to be in the strongest position.

It’s a curious thing that with so many millions of people suffering from unaddressed NASH, getting patients enrolled in clinical trials has been oddly difficult. It has tripped up both Intercept and Genfit.

That’s not because NASH is a fantasy, but because it is widely unrecognized by patients and physicians alike, and because it is hard to diagnose even when it is suspected. As a “silent” killer, it can advance without symptoms for a long time, before finally causing jaundice, fatigue, or weight loss in later stages.

Therefore, even a drug that successfully halts or reverses fibrosis (scarring) and/or resolves NASH (inflammation and some other factors) could have a tough time finding market traction.

Any company hoping to tap the NASH market will be counting on the development of biomarkers and diagnostics, as well as an education campaign—something that could favor the deeper-pocketed pharma companies.

Investment banking firm Cowen has estimated that 30% of patients with the disease are at the F3 (pre-cirrhosis) stage, with another 20% and the less advanced F2 stage. But a study from the New England Journal of Medicine suggests the numbers are smaller—with just 25% of patients at F2 or beyond. Gilead has suggested that there may be around 400,000 patients in the U.S. with diagnosed F3 or F4 NASH—still a very significant market, and one where a well-prepared company could potentially hit the ground running.

That also happens to fit right into the sweet spot for Gilead and what (little) we know about selonsertib. Gilead and Intercept are both expecting phase 3 readouts in the first half of 2019. Even if selonsertib doesn’t look as strong as Ocaliva, Gilead could develop a market while it continues to advance combination products—notably around its own FXR programs, similar to Ocaliva. Intercept may have a winner on its hands, but somebody else may still eat their cake.

https://www.biospace.com/article/is-nash-really-a-35-billion-opportunity-/

Brooks Automation Advances in Life Sciences with $450M Deal for Genewiz

Automation and cryogenics specialist Brooks Automation Inc. will increase its toehold in the life sciences industry with a $450 million all-cash acquisition of New Jersey-based GENEWIZ Group, a genomic services group.

The acquisition of privately-held Genewiz is the largest life sciences move Brooks Automation has made to date, said Steve Schwartz, president and chief executive officer of Brooks Automation. By acquiring Genewiz, Brooks will gain a company that specializes in the important area of gene sequencing and synthesis services. Genewiz has more than 4,000 global customers and has laboratories in multiple parts of the world, including the U.S., China, Japan, Germany and the United Kingdom.

For Brooks, the acquisition of Genewiz comes about a month after the company sold its semiconductor business for $675 million. At the time of that deal, Schwartz said the company planned to use the proceeds to accelerate the growth of its life sciences business, the Boston Business Journal reported. The Journal noted that Brooks largely built its business on the back of the semiconductor side of things, but in 2011 began to move further into the life sciences.

Schwartz said Brooks Automation eyed the Genewiz acquisition as more than just another asset to have in its portfolio. Schwartz said Genewiz will “add a new and innovative platform which we expect to leverage, along with our core capabilities, to add even more value to samples under our care.” Brooks, which is headquartered in Chelmsford, Mass., currently provides its cryogenics expertise to the life science industry. The company’s life sciences offerings include a broad range of products and services for on-site infrastructure for sample management in ‑20°C to -190°C temperatures, as well as comprehensive outsource service solutions across the complete life cycle of biological samples including collection, transportation, processing, storage, protection, retrieval and disposal.

“The Genewiz team has built a strong business, which customers trust to provide industry-leading scientific capabilities and superior service,” Schwartz said in a statement.

Amy Liao, co-founder and CEO of Genewiz, will continue to helm the company after it becomes a Brooks subsidiary.

“We bring 20 years of experience, leading sequencing and synthesis capabilities, deep customer relationships, and more than 1,000 very excited employees into Brooks.  We know that Brooks’ strength in the sample management market will open more doors to customers for our services and we look forward to developing this exciting new chapter of growth together as part of the Brooks team,” Liao said in a statement.

The deal is expected to close by the end of the year barring any unforeseen regulatory issues.

In its announcement, Brooks said it anticipates Genewiz will exceed $140 million in revenue over the next 12 months. That projection corresponds to Brooks’ fiscal year. The company said it anticipates the acquisition will immediately be accretive to non-GAAP earnings.

Shares of Brooks Automation are up slightly in premarket trading to $32.62. The stock fell more than 5 percent on Tuesday to close at $32.14.

https://www.biospace.com/article/brooks-automation-moves-further-into-life-sciences-with-450-million-deal-for-genewiz-group/