Stryker Misses the Goal with OP-1

01 Feb 2001

Analysts watching the progress of Stryker's OP-1, the first orthobiologic device to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended the product for European approval on January 3. But three weeks later, FDA sent Stryker a not-approvable letter. As it turned out, however, the OP-1 news, coincident with the company's announcement of strong financial results for 2000, barely put a dent in its stock price.

Analysts watching the progress of Stryker Corp. 's OP-1, the first orthobiologic product to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Only 100 patients were enrolled, the label indication—for the treatment of tibial nonunion fractures—was narrow, and both the treatment and control arms of the study used nails to fix the fractures, making it more difficult to ascribe any clinical benefit directly to OP-1.

Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended OP-1(osteogenic protein-1, also known as bone morphogenetic protein-7...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Podcast: Inside MoonLake’s Fast-Track Vision And $500m Deal

23 Jul 2025

• By Jo Shorthouse

MoonLake Immunotherapeutics is racing ahead in the biotech space with its innovative nanobody SLK and a transformative $500m non-dilutive financing deal. In this episode, its CEO and CFO discuss the company’s rapid clinical progress, financial strategy and ambitions to reshape inflammatory disease.

Rising leaders 2025: Aneesh Karatt-Vellatt On Maxion Therapeutics’ Antibody Revolution

22 Jul 2025

• By Jo Shorthouse

Aneesh Karatt-Vellatt is leading the charge to redefine how ion channels and G protein-coupled receptors (GPCRs) are targeted with antibody therapies, one of the most notoriously challenging classes of drug targets.

Podcast: Scancell’s Cancer Vaccine Progress With NHS Partnership

22 Jul 2025

• By Jo Shorthouse

In the latest podcast interview, Phil L'Huillier, CEO of Scancell, discussed the company's work in cancer vaccine development, and its selection as the first British biotech to be a part of the NHS Cancer Vaccine Launch Pad.

Podcast: “They Are Able To Keep Their Body”: Medipost On Its Stem Cell Therapy Vision

17 Jul 2025

• By Anabel Costa-Ferreira

In Vivo spoke with Edward Ahn, CEO of Medipost, a Korean company that has developed stem cell therapies from cord blood, on how they are working across regulatory markets to provide a novel treatment for degenerative diseases.

When Simple Is Best: A Pre-Term Birth Device To End The ‘Silent Emergency’

23 Jul 2025

• By Ashley Yeo

The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.