Mon, Sep. 12, 11:58 AM
- The first patient has been enrolled in a study assessing the use of Orthofix International's (OFIX +0.3%) pulsed electromagnetic field (PEMF) technology for the potential treatment of osteoarthritis (OA) of the knee. Specifically, the study will evaluate the safety and efficacy of the company's Physio-Stim system in reducing inflammation and restoring homeostasis of the extracellular matrix, with the aim of providing symptomatic relief from OA-related pain, reducing the breakdown of cartilage and stimulating the formation of new cartilage. If all goes well, this would be the first disease-modifying treatment for OA.
- The randomized, double-blind, placebo-controlled feasibility study will enroll ~150 subjects at least 40 years old at three U.S. sites. The primary endpoint is the change over time in a measure of arthritis called WOMAC score. According to ClinicalTrials.gov, the estimated completion date is July 2018.
- Physio-Stim is currently approved for the treatment of difficult-to-heal (nonunion) bone fractures. The device assists healing by delivering a non-invasive pulsed electromagnetic field signal to the targeted fracture site.
- According to a government estimate, almost half of people will develop symptomatic OA of the knee by age 85. In the U.S. there are ~700K knee replacement surgeries performed each year. The number is expected to increase to ~3.5M by 2030.
Mon, Aug. 1, 4:14 PM
Sun, Jul. 31, 5:35 PM
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Thu, Apr. 28, 4:30 PM
Wed, Apr. 27, 5:35 PM
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Mon, Feb. 29, 4:02 PM
- Orthofix (NASDAQ:OFIX): Q4 EPS of $0.28 beats by $0.05.
- Revenue of $104.6M (+4.3% Y/Y) beats by $2.17M.
Sun, Feb. 28, 5:35 PM
Tue, Jan. 12, 4:18 PM
Nov. 3, 2015, 4:31 PM
- Orthofix (NASDAQ:OFIX): Q3 EPS of $0.30 beats by $0.17.
- Revenue of $101.2M (+0.2% Y/Y) beats by $4.53M.
Nov. 2, 2015, 5:35 PM
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Aug. 4, 2015, 4:25 PM
- Orthofix (NASDAQ:OFIX): Q2 EPS of $0.36 beats by $0.27.
- Revenue of $100.95M (-0.0% Y/Y) beats by $4.73M.
- Shares +4.85%.
May 19, 2015, 7:20 AM
- Orthofix (OFIX +0.8%) Q1 results: Revenues: $89.8M (-10.2%); COGS: $19.3M (-28.0%); R&D Expense: $5.8M (-1.7%); SG&A: $65.4M (+12.0%); Operating Loss: ($7.2M) (-999%); Net Loss: ($7.7M) (-305.3%); Loss Per Share: ($0.41) (-272.7%); Quick Assets: $29.8M (-19.0%).
- 2015 Guidance: Net Sales: $385M - 390M; Adjusted EBITDA: $55M - 58M.
May 18, 2015, 4:08 PM
- Orthofix (NASDAQ:OFIX): Q1 EPS of -$0.15 misses by $0.23.
- Revenue of $89.8M (-11.4% Y/Y) beats by $0.3M.
May 17, 2015, 5:35 PM
Apr. 29, 2015, 4:27 PM
- Orthofix (NASDAQ:OFIX): FQ4 EPS of -$0.05
- Revenue of $100.3M (-5.3% Y/Y)
Apr. 24, 2015, 3:52 PM
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)