Sight Sciences

Sight Sciences said today that it launched a clinical trial of its Omni eye surgery device in sequential, minimally invasive glaucoma procedures.

Menlo Park, Calif.-based Sight Sciences said the 130-patient Gemini study is designed to evaluate the use of Omni in consecutive MIGS procedures involving transluminal viscoelastic delivery and trabeculotomy at 12 months. The single-arm trial’s primary outcomes are change in mean unmedicated diurnal intraocular pressure and change in mean number of IOP-lowering drugs. Secondary outcomes include percent of eyes with a more than 20% reduction in unmedicated diurnal IOP and percent of eyes with unmedicated diurnal IOP between 6mmHg and 18mmHg. The safety endpoints are the rate of ocular adverse events and best corrected visual acuity, according to ClinicalTrials.gov.

The estimate primary completion date is August 2020, with final completion slated for December next year.

“Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with performing multiple MIGS procedures during one surgery. Our goal of intervening earlier in the disease stage with multiple mechanisms of action is to generate the most efficacy possible while maintaining the optimal safety profile of MIGS,” Dr. Steve Vold, who performed the study’s first procedures, said in prepared remarks. “The Omni surgical system targets the three points of resistance in the conventional outflow pathway; this medical technology has the potential to become a leading option in the MIGS space.”

“Sight Sciences is committed to building upon a strong foundation of scientific evidence to help inform surgeons’ clinical decisions and help them select technologies that are best suited for their individual patients,” added chief medical officer Dr. Reay Brown. “We look forward to further confirming – via this large-scale, prospective, multicenter trial – that our sophisticated technology offers a compelling alternative to traditional treatments.”

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CHF Solutions touts reduced cost, hospital stays in Aquadex Flex Flow ultrafiltation study

CHF Solutions (NSDQ:CHFS) today released results from a study of its ultrafiltration, such as with its Aquadex Flex Flow system, as compared to diuretic therapy for treating heart failure patients, touting a reduction in hospital duration and readmissions.

The Eden Prairie, Minn.-based company said that results from the study were published in the Journal of Medical Economics.

In the study, investigators examined clinical data from literature and hospital data from the Healthcare Cost and Utilization Project to follow decision analytic framework and explored treatment decisions, costs and outcomes for treating heart failure patients with fluid overload with either ultrafiltration or diuretic therapy.

Results from the trial indicated that while the costs of ultrafiltration therapy were higher, fluid removal with ultrafiltration resulted in reduced hospital readmissions and cost savings of approximately $3,975, or 15%, when compared to diuretic therapy.

“We have for some time highlighted that one of the key advantages to ultrafiltration therapy with the Aquadex system was the cost savings to the hospital and the healthcare system in general. It is gratifying to have this claim validated in a peer-reviewed academic journal that covers economic assessments of therapeutics and medical device interventions.  We continue to believe that ultrafiltration therapy provides a much needed clinical alternative to diuretic therapy that also provides important economic benefits,” chair & CEO John Erb said in a press release.

Earlier this month, CHF Solutions said that a stock-and-warrants offering brought in more than $12 million.

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Another medtech sterilization plant will close in 2019

A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements.

The FDA warned on March 1 about a potential medical device shortage due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. The FDA said it isn’t aware of any device shortages attributable to the Willowbrook facility closure but that existing supplies could be diminished or depleted, leading to spot shortages.

Later this year, Viant will close a plant that uses ethylene oxide to sterilize medical devices in Grand Rapids, Mich., because, as it told nearby residents in an undated letter, “that work is not part of our core business.” The Viant plant sterilizes 46 types of devices, including catheters and surgical mesh, according to the FDA. Viant had self-reported an ethylene oxide leak to the Michigan Department of Environmental Quality (MDEQ) in 2017. The department issued a violation to Viant then and another following an MDEQ inspection in November 2018.

Get the full story on our sister site, Medical Design & Outsourcing.

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ConvaTec taps Bitar as CEO | Personnel Moves – March 26, 2019

ConvaTec (LON:CTEC) said today it tapped Karim Bitar as its new CEO, set to take the position on September 30.

Prior to joining the U.K.-based medtech company, Bitar served as CEO of agricultural biotech company Genus, holding the corner office position for approximately eight years.

Before his time with Genus, Bitar spent 15 years in various roles with Eliy Lilly, serving as prez of Europe, Australia and Canada.

“I am delighted to announce Karim’s appointment as chief executive officer of ConvaTec. He is an experienced and highly regarded leader with an excellent track record of delivering impressive results and transformational change within similar businesses. The board and I are very confident that Karim is the right person to lead ConvaTec through the next stage of the company’s development,” board chair Christopher Gent said in a press release.

“ConvaTec competes in attractive chronic care markets and has a solid portfolio of products and services. I am excited by the opportunity to lead ConvaTec to stronger and sustainable rates of profitable growth. ConvaTec has the potential to achieve market leadership across its franchises, by focusing on innovation and execution excellence and by leveraging its global presence,” Bitar said in a prepared statement.

 Monarch Medical names Lisanti as prez & CEO

Monarch Medical Technologies said yesterday that it named Bruce Lisanti as its new prez & CEO, replacing Linda Beneze who retired from the position.

Prior to joining the Charlotte, N.C.-based company, Lisanti has held leadership positions with a number of high-growth technology companies, including GE.

“On behalf of the board, we first would like to thank Linda Beneze for her contributions while leading Monarch and wish her all the best in her retirement. To continue the execution of the company’s vision, we are pleased to announce the appointment of Bruce Lisanti. With his extensive experience leading high-growth healthcare technology companies, Bruce is well-equipped to take the helm of Monarch and drive the continued advancement of the EndoTool Glucose Management system to help providers improve their clinical and financial outcomes through effective glycemic management,” Eigen Capital Holdings managing member Christophe Mallard said in a press release.

“I’m very excited to be joining Monarch at this moment in the healthcare industry and work with this phenomenal team to advance inpatient diabetes care. As more hospitals face financial pressures under value-based care payment models and increased competition with the rise of healthcare consumerism, the need to improve inpatient diabetes care is no longer just what is in the best interest of the patient, but also the provider’s bottom-line. EndoTool is well positioned as a proven solution to enhance the safety of insulin dosing, improve patient outcomes, and reduce the cost of care, benefiting both patients and providers,” Lisanti said in a prepared statement.

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 Baxter Americas prez Eyre to retire

Baxter (NYSE:BAX) said last week that its Americas president and senior VP Brik Eyre is retiring, effective June 30.

Eyre will be replaced by current global businesses prez & senior VP Giuseppe Accogli, the Deerfield, Ill.-based company said in an SEC filing.

Baxter said that Eyre will stay on as a non-executive in an advisory transition to support the transition, and that both Accogli and Eyre have begun to work on transition.

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 Micron Solutions CFO Welch retiring

Micron Solutions said last week that its existing CFO, treasurer and secretary Derek Welch has tendered their resignation, effective April 19.

The Fitchburg, Mass.-based company has not yet revealed plans to replace the departing finance head.

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 Fresenius creates global medical office

Fresenius Medical Care (NYSE:FMS; ETR:FRE) said last week that it named Dr. Frank Maddux as its new global chief medical officer and Dr. Robert Kossmann as its North America chief medical officer as part of the creation of a global medical office within the company.

The Waltham, Mass.-based company said that it is also lifting current Fresenius Kidney Care chief medical officer Dr. Jeffrey Hymes to the position of North American clinical and scientific affairs senior VP.

Fresenius Medical Care said that the newly created global medical office will look to advance teh application of clinical science and help spread knowledge across the company’s international network.

Maddux has been with Fresenius since 2009, and has held positions including clinical & scientific affairs exec VP and Fresenius NA chief medical officer.

Kossmann joined Fresenius in 2014 to oversee clinical research, development and distribution of products and pharmaceuticals within the company throughout North America, the company said.

“The creation of a global medical office under Dr. Maddux’s leadership will help us coordinate the interpretation of clinical science and medical practice patterns on a global basis. Delivering on our commitment to improve the quality of life of people living with kidney disease, Dr. Maddux and his team will pursue evolving medical opportunities, such as a more focused home offering. Dr. Kossmann and our great team of clinical leaders at Fresenius Medical Care North America will work to make an even greater impact through this improved global collaboration and focus on innovation,” Fresenius Medical Care NA CEO Bill Valle said in a press release.

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• Pavmed taps CFO McGrath as prez
• Millstone Medical adds Worthen as sales & biz dev exec VP
• Lantheus CMO Orlandi to retire
• Cantel Medical appoints Casner as HR chief, SVP
• Sonedo adds to leadership team

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Breath Therapeutics launches Ph3 trial for inhaled liposomal cyclosporine A therapy

Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome.

The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer.

Get the full story at our sister site, Drug Delivery Business News.

 

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Hydrocision, Procept BioRobotics ink licensing deal

Hydrocision said today that it inked an exclusive worldwide licensing deal to allow Procept BioRobotics to use its pump cartridge technology for urological applications.

Through the agreement, Redwood Shores, Calif.-based Procept BioRobotics will gain the rights to use Boston-based Hydrocision’s pump cartridge technology in its AquaBeam robotic system designed to performed autonomous tissue removal for treating benign prostatic hyperplasia.

“This global agreement with Procept BioRobotics is another significant and strategic step to bring the value of our differentiated technology into new surgical applications affecting millions of people around the world. This is yet another important validation of the value of our proprietary technology,” Hydrocision CEO Alain Tranchemontagne said in a prepared statement.

Procept BioRobotics will provide a one-time, upfront payment for the license, though neither company released details of the terms or payment amount.

“We are pleased to partner with Hydrocision to have immediate access to their unique pumping technology. Having the means to generate the required pressures to deliver high-velocity fluid streams with Hydrocision’s pump cartridge broadens our ability to deliver our proprietary Aquablation technology, which we developed as a core component of Aquablation therapy, a treatment that changes surgery as we know it,” Procept BioRobotics prez & CEO Nikolai Aljuri said in a press release

Hydrocision said that the licensing deal is the second it has inked, having previously granted Smith & Nephew (NYSE:SNN) a license for its FluidJet technology for use in wound care.

Earlier this month, Hydrocision said that it tapped former Smith & Nephew exec Alain Tranchemontagne as its new chief executive officer.

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Boston Scientific prevails in employment case

Boston Scientific (NYSE:BSX) has won summary judgment in an employment discrimination lawsuit brought by a former regional manager.

Boston Scientific fired the former manager, Michael Simons, in 2015 for impaired job performance due to alcohol consumption, being intoxicated at work events and getting arrested for drunken driving during work hours and failing to disclose the arrest, according to the facts of the case.

After the company issued two written warnings to Simons about his behavior, Simons emailed his supervisor citing complaints by Simons’ staff about the supervisor’s behavior. A company investigation found no wrong-doing.

Simons requested and was granted a 30-day leave to “address his alcoholism.” After his return to work, the company hired a private security team who turned up the DUI arrest. Boston Scientific subsequently fired Simons.

Simons sued the company and two superiors in New Jersey state court following his termination, alleging violations of state anti-discrimination law, the Family Medical Leave Act and a New Jersey employment protection law. Among his claims, Simons referred to the email to his supervisor as “whistleblowing,” although it included his promise to keep it confidential.

The state court ruled that Simons did not prove that Boston Scientific had discriminated against him for taking a leave of absence or that it had fired him for “purported whistleblowing.” A three-judge panel of the U.S. District Court for the Third Circuit agreed and dismissed the case.

Simons’ attorney did not immediately return a call for comment.

 

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