Glaukos touts 5-year study of glaucoma stents

Glaukos  (NYSE:GKOS) said today that a study of its iStent trabecular micro-bypass stents reduced eye pressure in glaucoma patients five years after implant. The same study showed that significantly fewer iStent patients needed add-on medications after five years, the company said.

The study showed that newly diagnosed, primary open-angle glaucoma (POAG) patients who received two iStents achieved a 35.3% reduction in mean intraocular pressure (IOP) to 16.5 mmHg. The prospective, controlled, multi-surgeon clinical trial pitted evaluated the five-year safety and efficacy of two iStents vs. topical prostaglandin as an initial intervention in POAG subjects who had not had prior glaucoma treatment. A total of 101 subjects were randomized in a 1:1 ratio to receive either two iStents in a standalone procedure or once-daily topical travoprost, a commonly prescribed prostaglandin. The results were published in Ophthalmology Glaucoma.

Treatment success — defined as mean diurnal IOP of 6 mmHg to 18 mmHg without add-on medication or secondary glaucoma surgery — was achieved in 77% of stent eyes vs. 53% of travoprost eyes (p = 0.04). Seventeen percent of stent eyes vs. 44% of travoprost eyes required add-on medication.

The need for add-on medication arose at a slower rate in the stent group than in the travoprost group, especially after two years of follow-up. Study authors observed that from two to five years of follow-up, add-on medications were initiated in roughly double the number of travoprost eyes vs. stent eyes. The safety profile was excellent in both groups throughout follow-up, according to the San Clemente, Calif.-based company.

“Topical ocular hypotensive medications are typical first-line glaucoma therapy but these drugs can be ineffective due to high rates of patient non-adherence, ocular surface damage, cost and other factors,” said ophthalmic surgeon and lead author Dr. Robert Fechtner in a prepared statement from Glaukos. “This study shows that not only are Glaukos’ iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.”

Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here.

“This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients,” said Glaukos prez & CEO Thomas Burns. “Moreover, it adds meaningful outcomes data to the growing body of peer-reviewed evidence that implantation of a single or multiple iStents can reliably achieve sustained IOP reductions in an elegant, tissue-sparing procedure with a highly favorable safety profile.”

Today’s announcement was good news for Glaukos, whose iStent recently fared worse in a two-year study that compared it to competitor Ivantis’ Hydrus Microstent. The Ivantis study touted reductions in medication use and no reoperations for patients in the Hydrus arm.




More device shortages pegged to sterilization plant shutdown

Cardinal Health’s Accu-Trace intrauterine pressure catheter (Image from Cardinal Health)

More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant.

Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned.

The letter from Cardinal Health (Dublin, Ohio) said that the company expects a shortage of its Kendall Accu-Trace intrauterine pressure catheter until early August. This device is placed inside a pregnant woman’s uterus to monitor uterine contractions during labor. The letter from Guerbet (Villepinte, France) said that disposable power injectors used with its Optistar, Optivantage and Illumena contrast delivery systems may experience shortages. Officials from those companies did not immediately respond to requests for comment.

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EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

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5 digital health startups you need to watch in 2019

(Image from Unsplash)

Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI).

Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began tracking these investments. From 2017 to 2018, the average deal size grew by $6 million. Machine learning companies cut 66 deals to raise $940 million, an 80% increase in funding compared to 2017. Patient empowerment received the most funding of any function in 2018, $3 billion across 193 deals.

Here are five of the up-and-coming digital health companies to watch in 2019:

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Synchron’s thought-to-text tech starts clinical trial

Synchron’s Stentrode technology is designed to restore communication to people with paralysis. (Image from Synchron)

Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis.

The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software and the stability of high-fidelity signals from the brain to external communications technologies.

Stentrode was designed to be small and flexible enough to safely pass through curving blood vessels in a procedure called cerebral angiography, eliminating the need for open brain surgery, according to Campbell, Calif.-based Synchron. By using blood vessels to deliver the technology to the brain, the technique may reduce risk of brain tissue rejection of the device, which has been a significant problem for other techniques, the company said. BrainOS is a modular training software powered by artificial intelligence that enables patients to control assistive technologies directly through thought.

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Mick Jagger is giving TAVR a boost: Here’s how

Mick Jagger TAVR

Mick Jagger during a concert in Warsaw, Poland in 2018 [Image by Jerzy Bednarski – Own work, CC BY-SA 4.0]

A successful transcatheter aortic valve replacement (TAVR) recovery for rock icon Mick Jagger could be good news for companies such as Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) that make devices for the procedure, according to analysts following the medical device industry.

The Rolling Stone frontman tweeted Friday that he was feeling better and on the mend after undergoing the procedure at a New York hospital.

“We think Mick Jagger’s TAVR procedure will likely raise awareness of aortic stenosis and potentially lead to more TAVR procedures which should benefit the TAVR manufacturers,” Wells Fargo analysts Larry Biegelsen, Lei Huang, Adam C. Maeder, Shagun Singh said in an equity research note dated yesterday.

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AirXpanders touts study results

AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems.

The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of CO2 up to three times a day.

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Irish medtech startup wins $3M in grants

The BioHealx technology is designed to treat anal fistula. (Image from Signum Surgical)

Galway, Ireland-based startup Signum Surgical said today that it has landed more than $3 million in grants to help fund its efforts to gain U.S. and European regulatory clearance of a device intended to treat a condition that can cause fecal incontinence.

The grants include $2.04 million from the European Union Horizon 2020 SME Instrument and $1.15 million from Ireland’s Disruptive Technologies Innovation Fund (DTIF). Part of the money will help Signum Surgical launch of a 12-month clinical study of its BioHealx device, which is designed to treat anal fistula. An anal fistula is an artificial tunnel between the rectum and skin of the buttocks that can develop due to an infected or blocked anal gland. If left untreated, an abscess may form, and the infection may travel through the patient’s sphincter muscle. The condition primarily affects young men and up to one in 5,000 people worldwide, according to a 2011 study published in Deutsches Ärzteblatt International. 

Current treatments are rarely successful, leaving patients to suffer from ongoing infections and causing many to undergo multiple procedures, according to the company. The BioHealx technology includes a bioabsorbable implant designed to help seal the fistula tract and dissolve in the body after treatment. The implant is placed via a minimally invasive, outpatient procedure designed to encourage healing, prevent reinfection, and protect patient continence, the company said.

The new grants follow a $2.3 million Series A investment round that closed in 2016. The Series A round was led by Halo Business Angel Network’s MedTech Syndicate, with additional investments from Enterprise Ireland, the Western Development Commission, Rising Tide Europe, and other angel investors.

“We are delighted to be awarded both the DTIF and Horizon 2020 SME grants, which validate the need for a viable solution where other approaches have been unsuccessful in treating this patient population,” said Signum Surgical co-founder and chief technology officer Eoin Bambury in a prepared statement. “With this funding, we look forward to accelerating the commercialization of BioHealx technology to help alleviate the suffering of people with anal fistulas — a debilitating condition that severely affects patients’ quality of life.”

Final defendant sentenced in insider trading case

Federal prosecutors have wrapped up an insider trading case based on alleged tips from a Bank of America consultant on pending corporate transactions, including Abbott‘s (NYSE:ABT) $25 billion acquisition of St. Jude Medical.

Rodolfo Sablon, 39, of Miami, Fla., was sentenced Friday to six months in prison for his role in the insider trading scheme based on tips from Bank of America technical consultant Daniel Rivas. U.S. District Judge Alison Nathan also sentenced Sablon to two years of supervised release, including six months in a community confinement center, and ordered him to pay $923,566 in forfeiture and a $5,000 fine. Sablon pleaded guilty in July 2018 to conspiracy to commit securities fraud and fraud.

In August 2017, U.S. authorities accused seven individuals of reaping more than $5 million in illicit profits based on tips from Daniel Rivas. Prosecutors said that childhood friends Rivas and Roberto Rodriguez conspired to trade on confidential information and colluded with Sablon, Rodriguez’s friend and roommate, to create an investment fund using proceeds from the inside trades with an ownership stake going to Rivas.

Rodriguez pleaded guilty in September 2018 to conspiracy to commit securities fraud and fraud in connection with a tender offer and was sentenced to one year and one day in prison, according to federal prosecutors. Michael Siva pleaded guilty in October 2018 to one count of conspiracy to commit securities fraud and fraud and was sentenced to 18 months in prison. Jhonatan Zoquier pleaded guilty in August 2018 to conspiracy to commit securities fraud and was sentenced to three months in prison. Jeffrey Rogiers pleaded guilty in August 2018 to conspiracy to commit securities fraud and was sentenced to three months in prison. The scheme brought in some $2 million in illegal profits, according to prosecutors. In all, tips from Rivas led to about $5 million in illegal gains, they said.

“Today’s sentencing of Rodolfo Sablon closes the book on this multimillion-dollar, multi-pronged insider trading scheme,” U.S. Attorney Geoffrey Berman said in a prepared statement. “Sablon and his co-defendants acted as though the securities laws that are designed to keep our nation’s marketplace fair did not apply to them. However, as they all have learned, our office is committed to identifying and prosecuting these types of insider trading networks.”

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Orthofix Medical touts data from artificial disc study

Orthofix Medical’s M6-C artificial cervical disc (Image from Orthofix)

A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today.

Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion (ACDF) patients, and 92% reported they were satisfied with the surgery, the Lewisville, Texas-based business said in a prepared statement.

At 24 months, patients in the ACDF group who were still using pain medications had a seven times higher rate of opioid use than those in the M6-C disc group, the study showed. In the M6-C group, 92% reported that were satisfied with the surgery.

“The results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty versus discectomy with fusion,” said Dr. Jack Zigler, an orthopedic spine surgeon at Texas Back Institute and an investigator in the study. “A significant reduction in pain, the maintenance or improvement of neurological function, and the preservation of natural disc motion after 24 months were all meaningful clinical benefits the M6-C disc patients experienced when compared to the fusion control.”

Zigler presented the study results during the International Society for the Advancement of Spine Surgery (ISASS) annual meeting in Anaheim, Calif.

A prospective, non-randomized, concurrently controlled clinical trial, the M6-C IDE study was conducted at 23 U.S. sites with an average patient age of 44 years. The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single-level symptomatic cervical radiculopathy with or without cord compression. The overall success rate for the protocol-specified primary endpoint for the M6-C disc patients was 86.8% at 24 months and 79.3% in the control group. This data statistically demonstrate that cervical disc replacement with the M6-C disc is not inferior to treatment with ACDF.

M6-C disc patients demonstrated statistically significant improvement in the Neck Disability Index as measured at week six and months three, six, 12 and 24. Before surgery, 80.6% of the M6-C disc patients and 85.7% of the ACDF patients were taking pain medication for the treatment of their cervical spine condition. At 24 months, the rate of M6-C patients still taking pain medication dropped to 14% compared to 38.2% of the ACDF patients. Of these, there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.

Average mean surgery time for the M6-C disc was 74.5 minutes versus 120.2 minutes for the ACDF procedure. M6-C patients also had shorter hospital stays and fewer needed follow-up surgery than ACDF patients.

The M6-C artificial cervical disc is made of ultra-high molecular weight polyethylene fiber wrapped in a specific pattern, with multiple redundant layers that create a fiber matrix (artificial annulus). The fiber is then wound around a polycarbonate urethane polymer core creating an artificial nucleus. Like a natural disc, this unique construct allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements, according to the company.

“With the recent FDA approval of the M6-C artificial cervical disc, we are excited to be able to provide spine surgeons and their patients a new and innovative alternative to the ball-and-socket artificial disc designs currently available in the U.S.,” said global president of Orthofix Spine Brad Niemann in a prepared statement. “What makes the M6-C disc so unique is its physiologic single-piece design featuring an artificial nucleus and annulus that work together to mimic the biomechanical motion of a natural disc to include axial compression or shock absorption, which no other disc available in the U.S. has to offer.”

Orthofix said it will release the M6-C disc in 2019 through a controlled, limited market launch in the U.S. accompanied by an extensive training and education curriculum for surgeons. The device CE Mark approval for distribution in the E.U. and other countries in 2006; there have been more than 45,000 implants of the M6-C artificial cervical disc outside of the U.S. to date.