Venus Concept to cut workforce by 18%

Venus Concept (Nasdaq:VERO) announced today that it plans to implement a restructuring plan that includes a large workforce reduction.

The medical aesthetic technology developer also intends to change up its executive leadership team amid the restructuring.

Venus Concept plans to cut 70 employees, equalling a reduction of approximately 18% of its global workforce as of Dec. 31, 2022. It completed the first phase of the reduction — impacting employees in Israel and North America — on Feb. 6.

Shares of VERO dipped 3.8% at 37¢ apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 12.3%.

In connection with the actions, Venus Concept expects restructuring charges between $2 million and $2.5 million. It intends to substantially settle those charges in cash. The company expects to realize the majority of its savings in the second half of 2023.

Ve…

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Neuron23 launches clinical trial for NEU-723 in Parkinson’s with companion diagnostic in development

South San Francisco–based Neuron23 has started the first-in-human Phase 1 trial of NEU-723 for the treatment of Parkinson’s disease. NEU-723 is a highly potent and selective leucine-rich repeat kinase 2 (LRRK2) inhibitor. This clinical trial will evaluate the safety, tolerability and pharmacokinetics of NEU-723 in healthy volunteers.

A targeted approach

The company has also collaborated with the diagnostics firm Qiagen to develop a companion diagnostic to identify a sub-population of Parkinson’s disease patients likely to respond to LRRK2 inhibitors.

“We wanted to try to narrow the population to those who would benefit and respond,” said Nancy Stagliano, chief executive officer of Neuron23. “So we built a machine learning model that can predict if patients respond to this drug or not.”

Stagliano says the targeted approach is “a big differentiator.” “To our knowledge, no one else has done this in neurodegenerative disease,” she said.

Th…

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FT011 yielded significant clinical improvements in more than 60% of scleroderma patients

Certa Therapeutics, a Melbourne-based biotech company, announced the results of its Phase 2 clinical trial for FT011, a novel oral therapy for chronic fibrosis.

The trial showed clinically meaningful improvements in more than 60% of scleroderma patients after 12 weeks of treatment.

In the Phase 2 study, 60% of patients treated with a 400 mg dose of FT011 showed a significant clinical improvement at 12 weeks while 20% of patients in the 200 mg did.

Several dimensions of improvement

Clinical trial investigators noted significant advances in lung function, patient self-assessment, and physician evaluation as measured by American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, skin thickness, lung function, physician-reported assessment and quality of life evaluations.

The drug candidate was well tolerated in the study.

FT011 targets a G protein-coupled receptor (GPCR), which is inactive in…

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Nipocalimab gets positive results in Phase 2 HDFN clinical trial

Johnson & Johnson subsidiary Janssen (NYSE:JNJ) has revealed positive results from the proof-of-concept Phase 2 UNITY clinical trial of nipocalimab for pregnant adults with a high risk of developing severe hemolytic disease of the fetus and newborn (HDFN).

HDFN is a rare condition affecting between 3 and 80 out of 100,000 newborns or fetuses each year. The serious autoimmune disease can lead to life-threatening anemia in the fetus.

The UNITY trial met its primary endpoint with most pregnant patients who received nipocalimab giving birth to a live baby at or after 32 weeks of gestation, without the need for intrauterine transfusions.

The treatment was administered as weekly intravenous infusions to 14 participants and was well-tolerated over a 20-week period.

FDA granted nipocalimab Fast Track designation in July 2019 and orphan drug status in June 2020.

Janssen acquired nipocalimab as part of its $6.5 billion acquisition of Momenta Phar…

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Qosina appoints former EssilorLuxottica exec as its EVP

Lee Pochter [Image courtesy of Qosina]

Qosina announced today that it’s appointed Lee Pochter as its executive vice president.

Pochter has more than 20 years of expertise in product strategy, business development, sales, marketing and supply chain management. Most recently, he was VP of the Alternative Lens Group at EssilorLuxottica.

“I look forward to the guidance Lee will bring to our team and the positive impact he will make in our organization,” Qosina CEO Scott Herskovitz said in a news release. “He is an accomplished leader with the vision and executive experience to help us implement our robust strategic plan and goals. His diverse background will be a valuable asset to Qosina.”

Pochter will lead Ronkonkoma, New York–based Qosina’s sales, finance, marketing, product development, …

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Qosina appoints former EssilorLuxottica exec as its EVP

Lee Pochter [Image courtesy of Qosina]

Qosina announced today that it’s appointed Lee Pochter as its executive vice president.

Pochter has more than 20 years of expertise in product strategy, business development, sales, marketing and supply chain management. Most recently, he was VP of the Alternative Lens Group at EssilorLuxottica.

“I look forward to the guidance Lee will bring to our team and the positive impact he will make in our organization,” Qosina CEO Scott Herskovitz said in a news release. “He is an accomplished leader with the vision and executive experience to help us implement our robust strategic plan and goals. His diverse background will be a valuable asset to Qosina.”

Pochter will lead Ronkonkoma, New York–based Qosina’s sales, finance, marketing, product development,…

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Tablet press maker Korsch acquires Medelpharm to boost R&D offerings

The combined Korsch-Medelpharm R&D equipment lineup [Image courtesy of Korsch]

Korsch AG recently announced that has acquired Medelpharm and its compaction simulator technology.

The financial terms of the deal were not disclosed.

Korsch said Medelpharm’s compaction simulator technology adds early-stage material characterization and scale-up capability to its R&D product portfolio.

The companies have 135-plus years of experience with small-scale, fully instrumented tablet compression equipment. The Korsch R&D product portfolio addresses and overcomes longstanding challenges, from early-stage powder characterization and formulation development, to predictive scale-up and production support.

The combined Korsch-Medelpharm R&D equipment lineup includes:

XP 1: Robust single-punch tablet press with small batch capabilities; STYL’One Nano: Benchtop compaction simulator…
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Trelleborg to expand biopharma manufacturing footprint in Europe

NEWS RELEASE: Trelleborg to Expand its BioPharma Manufacturing Footprint in Europe

This rendering shows Trelleborg’s plans for its Malta expansion. [Illustration courtesy of Trelleborg]

Trelleborg Healthcare & Medical announces a substantial investment to expand its European biopharmaceutical manufacturing capabilities in Malta. This follows a multimillion-dollar investment initiated in 2022 to expand biopharma capacities in North America.

Linda Muroski, President of Trelleborg Healthcare & Medical, says: “The site will initially add over 4,000 square feet of cleanroom space and focus on silicone tubing and braided hose with options to extend capabilities in the future. This is our second biopharma-focused manufacturing space alongside our BioPharma Center of Excellence in Northborough, Massachusetts in the U.S.”

The Malta site is one of Trelleborg’s largest manufacturing sites in Europe wi…

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Ulbrich expands Braid Wire Accelerator program

[Image courtesy of Ulbrich]

Ulbrich Specialty Wire Products (USWP) announced that it expanded its Braid Wire Accelerator program by making it available in Europe.

North Haven, Connecticut-based Ulbrich’s e-commerce solution rapidly delivers round and flat wire materials for manufacturing needs. Customers can, through just a few clicks, see alloys in stock, select materials and add products to their cart.

In February 2022, the company launched its e-commerce platform in North America. In a news release, Ulbrich said that it made the procurement tool available in Europe now following its successful North American rollout.

“I’m thrilled that the Braid Wire Accelerator has launched in Europe,” said Christian Prischmann, Ulbrich of Austria’s director of business development. “It will be easier than ever for our customers to source high-quality wire and beat their competitors to market.”

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3M faces more hurdles over earplug lawsuits strategy

Lawyers representing present and former U.S. military members want a U.S. bankruptcy judge to dismiss 3M subsidiary Aearo Technologies’ Chapter 11 filing.

The tort claimants committee filed a motion to dismiss in U.S. Bankruptcy Court in Southern Indiana on Feb. 3. They’ve long claimed that having Aearo file for bankruptcy was a strategy to deny the present and former servicemembers the relief they seek from hearing loss caused by allegedly defective earplugs. 3M potentially faces billions of dollars in losses from the more than 230,000 lawsuits.

Now the lawyers filing the lawsuits want Aearo’s bankruptcy case dismissed.

A ‘Texas two-step’ like J&J’s case?

Their dismissal motion came just days after Johnson & Johnson lost an appeal over an arguably similar “Texas two-step” type of strategy in which a spun-out LLC called LTL Management had filed for Chapter 11. In J&J’s case, the company fa…

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Sensydia completes enrollment in study for AI-powered cardiac monitoring device

[Image from Sensydia]Sensydia announced today that it completed enrollment in its 225-subject development study for its AI-powered Cardiac Performance System (CPS).

Los Angeles-based Sensydia designed the AI-based, non-invasive CPS to use heart sound analysis. It may enable earlier detection and improved therapy guidance for heart failure and pulmonary hypertension patients.

CPS uses ultra-sensitive biosensors for the rapid, non-invasive measurement of a number of cardiac metrics. These include ejection fraction, cardiac output, pulmonary artery pressure and pulmonary capillary wedge pressure. It all comes together in one handheld device, Sensydia said.

Normally, patients must undergo echocardiography and invasive catheterization to obtain these measurements. CPS offers fast and safe measurements and can be performed almost anywhere with minimal training, according to a news release.

Sensydia conducted the study at the University of Pittsburgh Medica…

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Freudenberg Medical expands medical tubing production to Massachusetts

NEWS RELEASE: Freudenberg Medical Expands Medical Tubing Production to Massachusetts

Multilumen tubing from Freudenberg [Photo courtesy of Freudenberg]

Freudenberg Medical, a global contract design and manufacturing provider to the medical device and pharmaceutical industry, has added custom silicone extrusion and medical and biopharma tube processing to its newest cleanroom manufacturing operation and global headquarters in Beverly, Massachusetts.

Freudenberg Medical is a leading global processor for custom medical and pharmaceutical tubing including multi-lumen, complex single lumen, and micro extrusions. The extrusion equipment and manufacturing processes installed in Massachusetts are identical to other Freudenberg Medical global locations for consistency and redundancy to alleviate customer supply chain risks.

“Freudenberg has added silicone extrusion capabilities in Massachusetts to better serve ou…

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