Medtronic exec: Google looms large as next great rival

May 7, 2014 by Brian Johnson

Medtronic executive Dr. Stephen Oesterle thinks Google will be a force to be reckoned with in the medical technology space in coming years.

As Medtronic‘s  (NYSE:MDT) resident technology scout and visionary, Dr. Stephen Oesterle’s job is to challenge the status quo at the world’s largest pure-play medical device company.

This morning Oesterle’s challenge to the medical device industry, issued at a meeting of the Massachusetts Medical Device Industry Council, was a sobering one.

 “Our arch-competitor in 20 years will not be Boston Scientific (NYSE:BSX) or St. Jude Medical (NYSE:STJ) or Covidien (NYSE:COV) or HeartWare (NSDQ:HTWR). It will be Google(NSDQ:GOOG). I am certain of it,” Oesterle told the audience at MassMEDIC’s annual conference today in Boston.

Oesterle, Medtronic’s senior vice president for medicine and technology, travels a quarter-million miles a year scouting new technologies, potential partnerships and other unique opportunities for Minnesota’s medtech Goliath. He also has access to an R&D budget that would make many of his colleagues jealous, but that’s nothing compared to what Google is spending, Oesterle said.

 

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North American Spine’s AccuraScope Procedure Featured on The Doctors TV Show

DALLASApril 8, 2015 /PRNewswire/ — North American Spine™, the exclusive provider of the AccuraScope® Procedure, was featured on The Doctors TV ShowApril 8, 2015. The segment was a follow up of a show that featured North American Spine on the program back in Dec. of 2013. Immediately after airing, North American Spine and the show received a flood of inquiries from viewers wanting to learn more about how the AccuraScope® Procedure changed lives.

Bernard Gonzalez was one of those callers. Gonzalez initially injured his back in high school and the pain got progressively worse over the years. He saw several specialists regarding his chronic pain but the physicians would only prescribe him medicine for pain management. Gonzalez and his wife Kim were at a standstill until they watched an episode of The Doctors TV Show featuring the AccuraScope procedure.

He called North American Spine and was confirmed as a candidate for the procedure. Gonzalez underwent the minimally invasive decompression procedures and it completely transformed his well-being. The Gonzalez family was invited to appear on the show and describe his inspiring story as a result of getting the AccuraScope procedure.

“We always keep searching and you never know when you’re going to find either your cure or the one thing that is going to improve your life drastically,” Dr.Travis Stork said to the Gonzalez family. “Clearly you found it.”

The Doctors TV Show’ original segment opened the world’s eyes to North American Spine’s innovative procedure that has relieved so many people from unbearable back pain.

“It’s so nice to see success stories like this one,” said Jon Sasser of North American Spine. “Bernie’s story is similar to hundreds we see each year. Helping to get people’s lives back to normal is our greatest reward at North American Spine. Watching the pure emotion from his wife about the pain he was in before the AccuraScope Procedure and how he’s pain-free now, is what drives us each day.”

To date, more than 8,000 AccuraScope procedures have been performed by board-certified physicians with specialty training. Medical research has shown that the AccuraScope procedure has an 82% success rate and saves patients an average of $23,190 in out-of-pocket costs over 5 years by reducing expenses including medical visits and medications.

“For The Doctors TV Show to feature a segment about the successes of North American Spine shows how popular the AccuraScope Procedure has become,” explained Sasser. “It’s giving hope to people suffering from chronic back pain.”

Medtech’s ROSA Robotic Surgery System to be Featured at the 84th American Association of Neurological Surgeons (AANS) Annual Meeting

MONTPELLIER, France, April 25, 2016 (GLOBE NEWSWIRE) — MEDTECH (Euronext, FR0010892950 – ROSA), a company specialized in designing, developing and marketing innovative surgical assistance robots, today announced that it will showcase its ROSA™ robotic surgery systems at the upcoming 84thAmerican Association of Neurological Surgeons (AANS) Annual Meeting, being held April 30 – May 4 in Chicago, IL.

Medtech’s ROSA™ robotic surgery system was developed to assist in a variety of minimally invasive neurological procedures while simultaneously increasing safety and reliability for the surgeon and patient. During the conference, Medtech will demonstrate the ROSA™ system at Booth #5035.

In addition, the ROSA™ robot will be featured at a workshop during the conference. Details of the workshop follow:

Title: 018 Stereotactic and Functional Neurosurgery – Hands-on Workshop
Date: May 1, 2016
Time: 7:30 a.m. – 4:30 p.m.

A ROSA™ robotic surgery system will be highlighted during functional neurosurgery sessions at AANS. The sessions will include discussions highlighting the minimally invasive approach that surgeons are able to utilize through ROSA™. Details of the sessions follow:

Title: Scientific Session III: Stereotactic and Functional
Date: May 2, 2016
Time: 2 p.m. – 5:30 p.m.

Title: AANS/CNS Section on Stereotactic and Functional Surgery
Date: May 3, 2016
Time: 2 p.m. – 5:30 p.m.

About the 2016 AANS Annual Scientific Meeting

Attended by neurosurgeons, neurosurgical residents, medical students, neuroscience nurses, clinical specialists, physician assistants, allied health professionals and other medical professionals, the AANS Annual Scientific Meeting is the largest gathering of neurosurgeons in the nation, with an emphasis on the field’s latest research and technological advances. More than 1,200 scientific abstracts were submitted for the 2015 AANS Annual Scientific Meeting. The scientific presentations accepted for the 2016 event will represent cutting-edge examples of the incredible developments taking place within the field of neurosurgery. Additional information about the 2016 AANS Annual Scientific Meeting and the meeting program can be found here.

About MEDTECH

Founded in 2002 by Bertin NAHUM and based in Montpellier, MEDTECH is a European specialist in the design, development and marketing of innovative robotic appliances to assist surgeons during their medico-surgical interventions, thus contributing to the implementation of safer, more efficient, less-invasive treatment.

In 2007, MEDTECH developed ROSA™,  an innovative technological device devoted to  brain surgery procedures.  ROSA™ has been approved in Europe,  the United States and Canada.

In 2013 MEDTECH received the “European Company of the Year Award” in the “robotic neurosurgery” category from Frost & Sullivan.

In July 2014, MEDTECH obtained the CE marking for its new product ROSA™ Spine, a robotic- assistive device for minimally invasive surgery of the spine.

In October 2014, MEDTECH won the “Révélation” prize in the Mediterranean Deloitte Technology Fast 50 Awards.

In 2015 MEDTECH received the “2016 Company of the Year Award” in the “robotic neurosurgery” category from Frost & Sullivan.

In November 2015, MEDTECH was honored by Deloitte In Extenso for its excellent performance in the Technology Fast 50 Mediterranean Awards, in the “listed company” category.

In January 2016, MEDTECH obtained the FDA clearance for its new product, ROSA™ Spine, a robotic-assistive device for minimally invasive surgery of the spine.

CONTACT: CONTACT MEDTECH
Christophe Sibillin
Chief Financial Officer
Tel : +33 (0)4 67 10 77 40

INVESTORS
Corinne Puissant
Tel : +33 (0)1 53 67 36 77
cpuissant@actus.fr

PRESS
Alexandra Prisa (EU)          
Tel. : +33(0)1 53 67 36 90 
aprisa@actus.fr                  

Joanna Zimmerman (US)
Tel : +1 646-536-7006
jzimmerman@theruthgroup.com

Osiris Therapeutics, Inc. to Re-list on The Nasdaq Global Market on August 1, 2018

COLUMBIA, Md., Aug. 01, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, today announced that The Nasdaq Stock Market LLC has approved its application to list its common stock on The Nasdaq Global Market. Osiris’s common stock will commence trading at the market open today, Wednesday, August 1, 2018, under the ticker symbol “OSIR”.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs. We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix®, BIO and Cartiform®. We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products. Osiris®, Grafix® and Cartiform® are our trademarks. BIO4® is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

For additional information, please contact:

Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com

NuVasive Announces Second Quarter 2018 Financial Results

SAN DIEGOJuly 31, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced financial results for the quarter ended June 30, 2018.

Second Quarter 2018 Highlights

  • Revenue increased 8.5% to $281.6 million, or 7.7% on a constant currency basis;
  • GAAP operating profit margin of 10.1%; Non-GAAP operating profit margin of 16.3%; and
  • GAAP diluted earnings per share increase of 5% to $0.22; Non-GAAP diluted earnings per share increase of 29% to $0.58.

“We are pleased with our second quarter total revenue growth of 8.5% year-over-year driven by momentum in our U.S. Spinal Hardware business where we saw spine case volumes up nearly 7% versus prior year,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “We continue to see strong demand for new product introductions from late last year and positive surgeon conversion efforts as our new Lateral Single-Position Surgery procedure gains traction in the market. Our International business also delivered a solid performance with 21% year-over-year growth.”

A full reconciliation of GAAP to non-GAAP measures can be found in the tables of this news release.

Second Quarter 2018 Results

NuVasive reported second quarter 2018 total revenue of $281.6 million, an 8.5% increase compared to $259.4 million for the second quarter 2017. On a constant currency basis, second quarter 2018 total revenue increased 7.7% compared to the same period last year.

For the second quarter 2018, GAAP and non-GAAP gross profit was $204.5 million and $204.9 million, respectively, and GAAP and non-GAAP gross margin was 72.6% and 72.8%, respectively. These results compared to both GAAP and non-GAAP gross profit of $193.2 million, and both GAAP and non-GAAP gross margin of 74.5% for the second quarter 2017. Gross margins for the second quarter 2018 were impacted by the Company’s in-source manufacturing efforts at the West Carrollton facility, which are expected to improve over the second half of 2018.

The Company reported GAAP net income of $11.5 million, or $0.22 per share, for the second quarter 2018 compared to GAAP net income of $12.2 million, or $0.21 per share, for the second quarter 2017. On a non-GAAP basis, the Company reported net income of $30.3 million, or $0.58 per share, for the second quarter 2018 compared to net income of $23.6 million, or $0.45 per share, for the second quarter 2017.

Annual Financial Guidance for 2018 

The Company updated its full-year 2018 guidance as follows:

2018 Guidance Range 1

Prior

Current

(in million’s; except %’s and EPS)

 GAAP 

 Non-GAAP 

 GAAP 

 Non-GAAP 

Revenue

$    1,095

$    1,105

$ 1,095

$    1,105

$ 1,095

$ 1,105

$ 1,095

$ 1,105

  % Growth – Reported 2

6.7%

7.6%

6.7%

7.6%

6.7%

7.6%

6.7%

7.6%

% Growth – Constant Currency 2, 3

5.7%

6.6%

6.3%

7.3%

Operating margin

9.6%

9.7%

17.6%

17.6%

8.0%

8.1%

16.7%

16.7%

Earnings per share

$      0.71

$      0.74

$   2.44

$      2.47

$   0.45

$   0.48

$   2.37

$   2.40

EBITDA

19.5%

19.5%

26.9%

26.9%

18.7%

18.7%

25.9%

25.9%

Tax Rate

~31%

~31%

~23%

~23%

~33%

~33%

~21%

~21%

  1

Prior guidance reflects the range provided May 1, 2018. Current guidance reflects the range provided July 31, 2018.

  2

2017 has been recasted and presented based on our full retrospective method of adoption of ASC 606.

 3

Constant currency is a measure that adjusts US GAAP revenue for the impact of currency over the same period in the prior year.

  • Full-year 2018 revenue remains in the range of $1,095 million to $1,105 million reflecting reported growth of 6.7% to 7.6%, and growth in the range of 4.7% to 5.7%, exclusive of the SafePassage acquisition;
  • Non-GAAP diluted earnings per share in a range of $2.37 to $2.40 compared with the prior expectation of $2.44 to $2.47;
  • Non-GAAP operating profit margin of approximately 16.7% compared with the prior expectation of 17.6%;
  • Adjusted EBITDA margin of approximately 25.9% compared with the prior expectation of 26.9%;
  • Non-GAAP effective tax expense rate of approximately 21%, compared with the prior expectation of approximately 23%;
  • The Company expects currency to have a positive impact on revenue in 2018 of approximately $3 million compared with the prior expectation of $10 million; and
  • The Company expects to drive an adjusted EBITDA of approximately $283 million to $293 million.

The above guidance assumes a full-year benefit of U.S. tax reform, suspension of the medical device tax and the SafePassage acquisition.

Supplementary Financial Information

For additional financial detail, please visit the Investor Relations section of the Company’s website at www.nuvasive.comto access Supplementary Financial Information.

Reconciliation of Full Year EPS Guidance

2017

Actuals1, 2

2018 Guidance Range

Prior1, 3, 4

Current  1, 3, 5

GAAP net income per share

$       1.48

$  0.71

$  0.74

$  0.45

$  0.48

Impact of change to diluted share count

0.08

0.01

0.01

GAAP net income per share, adjusted to diluted Non-GAAP share count

$       1.56

$  0.72

$  0.75

$  0.45

$  0.48

Business transition costs 6

0.08

0.07

0.07

0.13

0.13

Non-cash purchase accounting adjustments on acquisitions 7

0.01

0.02

0.02

0.02

0.02

Non-cash interest expense on convertible notes

0.33

0.32

0.32

0.32

0.32

Litigation related expenses and settlements 8

0.09

0.55

0.55

0.60

0.60

Non-recurring consulting fees 9

0.12

0.12

0.13

0.13

Impairment of strategic investment

0.17

0.17

0.17

0.17

Amortization of intangible assets 10

0.89

0.89

0.89

0.95

0.95

Tax effect of adjustments 11

(1.08)

(0.42)

(0.42)

(0.40)

(0.40)

Non-GAAP earnings per share

$       1.89

$  2.44

$  2.47

$  2.37

$  2.40

GAAP Weighted shares outstanding – basic

50,874

51,025

51,025

51,397

51,397

GAAP Weighted shares outstanding – diluted

55,193

52,647

52,647

52,131

52,131

Non-GAAP Weighted shares outstanding – diluted 12

52,345

52,185

52,185

52,131

52,131

1

Items may not foot due to rounding.

2

2017 has been recasted and presented based on our full retrospective method of adoption of ASC 606 as well as for expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property.

3

Prior guidance reflects the range provided May 1, 2018. Current guidance reflects the range provided July 31, 2018.

4

Effective tax expense rate of ~31% applied to GAAP earnings and ~23% applied to Non-GAAP earnings.

5

Effective tax expense rate of ~33% applied to GAAP earnings and ~21% applied to Non-GAAP earnings.

6

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

7

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

8

Related to the Medtronic litigation matter for fiscal year 2017. Represents the settlement loss in connection with the Madsen Medical, Inc. litigation matter as well as expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property for fiscal year 2018.

9

Non-recurring consulting fees associated with the implementation of our state tax-planning strategy.

10

2017 results exclude the amortization associated with non-controlling interest.

11

The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Company’s tax filings. The impact of the changes to the tax rate results in an annual estimated rate of ~33% on a GAAP basis and ~21% on a non-GAAP basis.

12

Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible notes and warrants for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

Michigan Neurosurgeon Featured as a “Spine Surgeon to Know” by Becker’s Spine Review

MADISON HEIGHTS, MICHIGAN (PRWEB) FEBRUARY 22, 2017
Becker’s Spine Review, the leading publication featuring news and analysis of issues related to spine practices, is featuring Michigan neurosurgeon Jay Jagannathan, M.D., as a “Spine Surgeon to Know.” Dr. Jagannathan is known as one of a small number of neurosurgeons in Michigan performing minimally invasive back surgery that often results in less post-operative discomfort and a quicker recovery for patients.

Dr. Jagannathan founded and heads the Jagannathan Neurosurgical Institute – with clinical-office locations in the Detroit area (Madison Heights, Garden City, Dearborn and soon in Troy), central Michigan (West Branch) and far-northern Michigan (Sault Sainte Marie). The practice has specialists in neurosurgery, neurology and pain management and provides interdisciplinary treatment for patients with spine and other neurological disorders throughout the state of Michigan. “It is a great honor to be featured by Becker’s Spine Review,” said Dr. Jagannathan of the Jagannathan Neurosurgical Institute. “We are recognized for the specialty expertise in minimally invasive spine surgery, which our patients really appreciate, and also our unusual reach in the state of Michigan – with office locations and my ability and willingness to travel to be nearby just about anyone in Michigan, regardless of where they live in the state.”

Dr. Jagannathan is a Diplomate of the American Board of Neurological Surgery, the American Academy of Neurological and Orthopedic Surgery and the American Board of Spinal Surgery. He has been a “Featured Neurosurgeon” in Hour Detroit magazine’s ‘Top Docs’ issue in 2014, 2015 and 2016. He received the Patients’ Choice Award and Compassionate Doctor Recognition from Vitals.com in 2014, 2015 and 2016. In 2016 he was rated the Top Neurosurgeon in Metro Detroit by RateMDs.com. Dr. Jagannathan received his M.D. degree from the University of Maryland School of Medicine. His neurosurgery residency was at the University of Virginia Health Sciences Center and the Wayne State University School of Medicine where he was Chief Resident. He is a Fellow of the American Association of Neurological Surgeons.

Dr. Jagannathan has published numerous papers and book chapters in the areas of spine surgery, radiosurgery and neuro-oncology and has been the recipient of numerous awards including the Synthes Award for craniofacial research as well as the Cone Pevehouse Award for socioeconomic research, both from the American Association of Neurological Surgeons. He was named a ‘rising star’ in spine surgery by In-Spine magazine.

He is actively involved in organized neurosurgery and served as a member of the American Association of Neurological Surgeons (AANS) Young Neurosurgeons Committee and on the Executive Committee of the Section on Tumors. He also represented Michigan on the Council of State Neurosurgical Societies.

Dr. Jagannathan is a resident of Birmingham, Mich.