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MedTech 100 roundup: Industry climbs again

The medtech industry built off a strong performance two weeks ago with another uptick in the midst of an up-and-down year.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 18) at 110.64 points, producing a 0.9% rise from the 109.63-point mark set one week prior (June 11). In all, the industry has risen 3.4% over the past two weeks.

The recent upswing provides a welcome sight after the industry’s progress came to a halt with a -1.4% dip earlier this month. The index looks poised to pick up again as it nears the high points registered when April brought the industry’s all-time best performance.

Even with some recent setbacks, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered an 19.8% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 78.1% increase from the …

Ortho surgical software firm Enhatch raises $9M

AI-enabled surgical software company Enhatch announced today that it raised $9 million in a recent funding round.

Led by software growth equity firms Trousdale Capital and Apis Holdings, the latest round brings Enhatch’s total fundraising to $15 million. It has also enabled the Hoboken, N.J.-based company to double its staff to 40. One-third of employees are located in Tulsa, Okla., holding positions in dev ops (software development and IT operations), sales, marketing and customer success.

Enhatch’s software is designed for orthopedic and spine device manufacturers and surgeons.

“A key objective with this funding is to integrate Intelligent Surgery into every aspect of the medical device industry and to ensure our partners have an enterprise-level customer experience,” says Enhatch CEO Peter Verrillo in a news release. “We are committed to providing a robust, end-to-end solution that allows surgeons to work more efficiently, procedures to become m…

Athira Pharma’s stock falls 39% after placing its CEO on leave

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave.

The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020.

Washington State University has launched an independent review of Kawas’s doctoral research in molecular pharmacology and toxicology, which she completed a decade ago.

The university is investigating reports that Kawas authored several papers with altered images.

Get the full story from our sister site, Drug Discovery & Development.

Athira Pharma’s stock falls 39% after placing its CEO on leave

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave.

The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020.

Washington State University has launched an independent review of Kawas’s doctoral research in molecular pharmacology and toxicology, which she completed a decade ago.

The university is investigating reports that Kawas authored several papers with altered images.

Several papers Kawas had co-authored now appear on PubPeer, which cites possible problems with published research. PubPeer authors have pointed out that specific images in those papers appear to have duplicated portions and other irregularities. Some of the anomalies could have led to incorrect research findings or at least the interpretability of those findings.

In the interim, the company has…

Moderna to expand its Massachusetts manufacturing capabilities

Cambridge, Mass.–headquartered Moderna (NSDQ:MRNA) will hire at least 155 new manufacturing employees for manufacturing jobs at its plant in Norwood, Mass.

A $2.33 million tax incentive from the Massachusetts Life Sciences Center helped bankroll the expansion. The investment will enable the company to double the size of its manufacturing site in Norwood, Mass., which became operational in 2018.

With limited manufacturing capability, Moderna has had to rely on partners with contract manufacturers such as Lonza(SWX:LONN), Catalent (NYSE: CTLT), Baxter BioPharma Solutions (NYSE: BAX), Recipharm and Laboratorios Farmacéuticos Rovi (BME:ROVI).

Get the full story from our sister site, Pharmaceutical Processing World.

Moderna to expand its Massachusetts manufacturing capabilities

Cambridge, Mass.–headquartered Moderna (NSDQ:MRNA) will hire at least 155 new manufacturing employees for manufacturing jobs at its plant in Norwood, Mass.

A $2.33 million tax incentive from the Massachusetts Life Sciences Center helped bankroll the expansion. The investment will enable the company to double the size of its manufacturing site in Norwood, Mass., which became operational in 2018.

With limited manufacturing capability, Moderna has had to rely on partners with contract manufacturers such as Lonza (SWX:LONN), Catalent (NYSE: CTLT), Baxter BioPharma Solutions (NYSE: BAX), Recipharm and Laboratorios Farmacéuticos Rovi (BME:ROVI).

COVID-19 vaccine sales are fueling more growth. The company anticipates that it will generate $19.2 billion in revenue this year. That level of revenue would likely catapult the company into the top 20 pharmaceutical companies. For context, the top two pharma companies had approximately $50 billion in revenue in 2020.<…

Senator Manchin asks Biden to oust Woodcock over Aduhelm row

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB).

The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand the resignations from prominent FDA officials.

Get the full story from our sister site, Pharmaceutical Processing World.

Senator Manchin asks Biden to oust Woodcock over Aduhelm row

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB).

The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand the resignations from prominent FDA officials.

Manchin also voiced concerns about the ongoing lack of permanent leadership as Dr. Janet Woodcock continues to serve as acting commissioner of the agency. Woodcock began her tenure as acting commissioner after Biden’s inauguration. She has worked at the agency since 1986.

Manchin asked Biden to make the FDA explain why it chose to ignore the advice of an external advisory committee, which had recommended that the agency not approve the drug without additional data.

Three members of that advisory committee have since…

Latest iCad 3D mammography AI gains CE mark

iCad’s latest AI for digital breast tomosynthesis provides a case score for each detection. (Image courtesy of iCad)

iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval.

Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level, and approximately 40% faster processing on the new PowerLook platform, according to the Nashua, N.H.–based company.

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

Spino Modulation vertebral body tethering device wins FDA breakthrough device designation

Spinologics’s Spino Modulation today announced that it received FDA breakthrough device designation for its MIScoli vertebral body tethering device.

Spino Modulation designed the system to treat scoliosis in young adolescents.

Vertebral body tethering (VBT) is a less invasive alternative to spine fusion, which is the standard of care for adolescents who need surgery to correct a curvature of the spine. According to the company, MIScoli is one of a few VBT devices under investigation or limited market release in many countries.

Spinologics is performing an ongoing clinical trial to research the MIScoli system as a treatment option for idiopathic scoliosis to reduce deformity and prevent its worsening in growing children who are at high risk for curve progression while also preserving motion.

Contract manufacturers fuel medtech expansion in Costa Rica

Medical device manufacturing is flourishing in the Central American country, spurred by a host of incentives.

[Image from Unsplash]This year is seeing a wave of expansions by medtech contract manufacturers in Costa Rica.

Medtech OEMs have made the Central American company a manufacturing hub since the 1990s. Major companies operating there include Abbott, Bayer, Boston Scientific, Cardinal Health, Edwards Lifesciences, Hologic, Medtronic, Philips, Smith+Nephew and Wright Medical. Eight of these are among the top 20 exporters in Costa Rica, representing nearly $2.7 million in medical device exports in 2019 — 73% of the total.

Medtech OEMs in Costa Rica want their suppliers nearby, making the Central American country a magnet for contract manufacturers. The addition of medtech sterilization facilities in Costa Rica — BeamOne (now Steris) in 2009 and Sterigenics in 2013 — also helped spur more contract manufacturing. Before that, manufacturers had to ship prod…

Sepha unveils high performance leak tester for pharma packaging testing

Leak-testing and packaging specialist Sepha (Belfast) is launching a leak tester for container closure integrity testing (CCIT) applications that can detect leaks as small as 1 µm.

Known as the Multi-Q HD, the device supports the non-destructive detection of defects in pharmaceutical containers including parenteral packaging formats, which have experienced growth during the pandemic, thanks to mass-vaccination campaigns.

Even micro cracks and pinholes can negatively impact the shelf life and product efficacy of a range of pharmaceuticals. In terms of parenteral packaging, the Multi-Q HD supports a range of formats including glass or plastic vials, ampules, pre-filled syringes, bottles and blow-fill-seal containers.

Sepha Managing Director Paul Smith noted in a press release that the historic benchmark for CCIT had been 5 μm, but the industry has pushed to “raise the bar for increased integrity test sensitivity.” The trend has only accelerated during the …