Sun, May 10, 6:46 PM
- The FDA approves Nevro's (NYSE:NVRO) Senza spinal cord stimulation system (NYSE:SCS) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza system's value proposition is the reduction of pain without paresthesia or tingling sensation, which typically characterizes SCS therapy and that many patients find uncomfortable. Senza avoids paresthesia by delivering high frequency stimulation (10 KHz) and low stimulation amplitudes.
- The FDA also clears Senza for stimulation below 10KHz, which requires paresthesia.
- Related tickers: (NYSE:MDT) (NYSE:BSX) (NYSE:STJ)
Thu, May 7, 5:54 AM
Thu, Apr. 30, 10:10 AM
- The FDA approves St. Jude Medical's (STJ -1.6%) Protege MRI spinal cord stimulation (SCS) system, and MRI compatibility of the 60cm Octrode percutaneous leads for use with the device, for the treatment of chronic pain.
- The Protege MRI is the smallest MR-conditional SCS implantable pulse generator (IPG) available in the U.S. and the only upgradeable IPG that allows patients to safely undergo head and extremity MRI scans.
- SCS therapy uses a small implanted generator to deliver electrical pulses to the spinal column via leads with electrodes. The pulses mask or interrupt pain signals as they travel up the spinal column to the brain thereby reducing the sensation of pain.
Tue, Apr. 28, 1:31 PM
- DaVita Healthcare Partners (DVA -0.2%) upgraded to Outperform with a $95 (14% upside) by Baird.
- St. Jude Medical (STJ +0.5%) upgraded to Outperform with a $84 (15% upside) price target by Credit Suisse.
- Omnicare (OCR -0.3%) downgraded to Sector Perform with a $82 (5% downside risk) price target by RBC Capital and to Neutral by Credit Suisse with a $91 (6% upside) price target.
Wed, Apr. 22, 8:10 AM
- St. Jude Medical (NYSE:STJ) Q1 results ($M): Total Revenues: 1,345 (-1.3%); U.S.: 681 (+5.7%); Intl: 664 (-7.6%); ICD: 411 (-5.7%); Pacemakers: 232 (-7.6%); AF: 270 (+7.6%); Cardiovascular: 324 (-0.6%); Structural Heart: 147 (-4.5%); Vascular: 177 (+2.9%); Neuromodulation: 108 (+9.1%).
- Net Income: 262 (+5.2%); EPS: 0.93 (+8.1%).
- Q2 Guidance: Revenues: $1.370B - 1.395B; GAAP EPS: $0.86 - 0.88; Non-GAAP EPS: $0.99 - 1.01.
- 2015 Guidance: Revenues: $5.440B - 5.515B from $5.45B - 5.55B; GAAP EPS: $3.54 - 3.59 from $3.50 - 3.55; Non-GAAP EPS: $3.92 - 3.97 from $3.95 - 4.00.
Wed, Apr. 22, 7:17 AM
Tue, Apr. 21, 5:30 PM
Mon, Apr. 20, 1:07 PM
- St. Jude Medical (STJ +0.8%) exercises its option to acquire Menlo Park, CA-based Spinal Modulation for $175M plus additional payments based on FDA clearance of the Axium Neurostimulator System and the achievement of certain revenue targets.
- The company has had a relationship with Spinal Modulation since January 2013, when it secured exclusive rights to distribute Axium in ex-U.S. territories. It also made a $40M equity investment in the intraspinal neuromodulation therapy firm.
- St. Jude expects to complete the transaction this quarter.
Tue, Feb. 24, 9:43 AM
- The FDA grants 510(k) clearance to privately-held Bioness' StimRouter, an implantable neuromodulation device for the treatment of chronic pain of peripheral nerve origin. It is the first implanted device with a specific indication for peripheral nerve stimulation.
- The system consists of an implanted lead , an external pulse transmitter and conductive electrode and a small hand-held wireless control unit.
- Bioness is yet another medical products firm started by serial entrepreneur Al Mann, the force behind Second Sight Medical Products (EYES +21.3%), MannKind (MNKD -1%), Advanced Bionics and MiniMed.
- Neuromodulation-related tickers: (MDT -0.3%)(STJ -1.9%)(BSX)(NURO)
Fri, Feb. 20, 2:48 PM
Wed, Jan. 28, 7:57 AM
- St. Jude Medical (NYSE:STJ) Q4 results ($M): Revenues: 1,439 (+1.2%), International: 761 (-2.6%), U.S.: 678 (+5.8%); ICD: 426 (-3.6%); Pacemakers: 259 (-1.5%); AF: 283 (+12.3%); Cardiovascular: 347 (-0.9%); Neuromodulation: 124 (+7.8%).
- COGS: 425 (-1.2%); R&D Expense: 175 (-5.9%); SG&A Expense: 457 (-3.8%); Net Income: 245 (+99.2%); EPS: 0.84 (+100.0%); Quick Assets: 1,442 (+5.0%).
- Gross Profit: 1,014 (+2.2%); COGS: 29.5% (-2.3%); Gross Margin: 70.5% (+1.0%); Operating Earnings: 382 (+15.4%); Operating Earnings Yield: 26.5% (+14.0%); Net Earnings Yield: 17.0% (+96.8%).
- 2015 Guidance: EPS: $3.50 - 3.55; Non-GAAP EPS: $3.95 - 4.00; Revenues: $5.45B - 5.55B.
- Q1 Guidance: EPS: $0.77 - 0.70; Non-GAAP EPS: $0.90 - 0.92; Revenues: $1.305B - 1.320B.
Wed, Jan. 28, 7:17 AM
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Wed, Jan. 14, 9:56 AM
- St. Jude Medical (STJ +1.1%) announces preliminary revenues for Q4 and its authorization of a $500M share repurchase program.
- Q4: Net sales: ~$1.439B; CRM: $685M, ICD: $426M, Pacemakers: $259M; Atrial fibrillation: $283M; Cardiovascular: $347M, Structural Heart: $159M, Vascular: $188M; Neuromodulation: $124M.
- The company will report final results on January 28 before the open.
Tue, Jan. 6, 8:13 PM
STJ vs. ETF Alternatives
St Jude Medical Inc develops, manufactures and distributes cardiovascular medical devices for global cardiac rhythm management, cardiovascular, atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain.
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