Camber Spine Announces Hitting $1M Milestone With SPIRA™-C In Less Than 6 Months

Aurora Spine Announces European Patent Related To ZIP Minimally Invasive Spinal Implant

CARLSBAD, Calif., Oct. 25, 2018 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSXV:ASG) (“Aurora Spine” or the “Company”) announced today the grant by the European Patent Office (the “EPO”) of Aurora’s first European patent related to the ZIP®, minimally invasive spinal implant. The patent is titled “Dynamic and Non-Dynamic Interspinous Fusion Implant and Bone Growth Stimulation System”, and covers Aurora’s family of ZIP® interspinous devices, including its ZIP Ultra®, ZIP 51™, ZIP LP™ and Dyna-ZIP™ among others.  The EPO has reported that no oppositions have been filed against the European patent.

“The recent European ZIP® Interspinous patent allowance is another milestone in Aurora Spine’s history. This newly issued patent features our patented ONE-STEP™ locking mechanism that eliminates the use of a set screw in Aurora’s Screwless Procedure™ surgeries,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine and Co-Inventor of the ZIP. “The ZIP technology provides Aurora Spine with opportunities to market, license and develop its products and screwless, minimally invasive implant technology further. We are very proud of the progress that we have made over the past couple of years in spinal surgery and the remarkable value that Aurora Spine`s intellectual property has added to our company`s growth.”

“Aurora is changing spine surgery, and we are thrilled that our newest patent has been issued by the EPO. This patent further validates the modern advancements of our Screwless technology and it maintains our commitment to introduce advanced minimally invasive spine surgery technologies,” said Trent Northcutt, President and CEO of Aurora Spine.

This is Aurora Spine’s first European patent. Aurora Spine has several U.S. and international patent applications pending directed to the ZIP system and its future technologies.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies.  Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the Offering and the proposed use of proceeds of the Offering. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

For more information, please contact:

Aurora Spine Corporation

Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

Sarina Mason
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com

SpinalCyte Announces Positive 12 Month Pain Data From Phase 1/Phase 2 Clinical Trial for Degenerative Disc Disease

October 25, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts (HDFs), today announced 12-month endpoint data from its Phase 1/Phase 2 clinical trial for treatment of degenerative disc disease (DDD). The analysis showed that patients who received intradiscal injections of the HDF product CybroCell™ had sustained improvement in pain relief and increased back mobility after 12 months. The sustained pain relief suggests that there is a regenerative process stimulated by its cell-based therapy, CybroCell. CybroCell is the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease.

The landmark Phase 1/Phase 2 clinical trial included 24 patients with chronic lower back pain caused by DDD. The patients’ pain levels were measured using the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS) at 6 and 12-months post-treatment. At the 12-month endpoint, more than 90% of the treatment group had over a 10-point reduction in ODI and 100% had improvement in VAS. On average, treatment group patients showed a 61% improvement over baseline ODI scores, compared to 29% improvement in the placebo group. Patients received intradiscal injections in one to three spinal discs and were randomly assigned to treatment groups which received: a saline injection, an injection of 10 million HDFs or an injection of 10 million HDFs in combination with platelet-rich plasma (PRP).

Previous MRI data from the 6-month endpoint demonstrated superior outcomes in the treatment versus the control group. Of the treatment group, 83% demonstrated increased disc height or no change in one or more discs compared to 66% of control patients. More than half 52% of CybroCell-treated discs showed either increased disc height or no change versus only 38% of control discs. Preclinical animal studies have demonstrated that an intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn regenerate the disc nucleus.

“We are encouraged by the significant pain reduction of the CybroCell patients over the control patients,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “CybroCell has demonstrated clinically relevant outcomes in the area of pain reduction for those patients who received treatment injections. The data suggests CybroCell possesses tangible pain reduction benefits for people suffering from degenerative disc disease, a chronic condition for which previous treatments have not demonstrated a physical improvement in the degenerated disc.”

“We are excited about the sustained pain reduction we witnessed in the treatment arm patients from 6 months to 12 months,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “This study provides evidence of long-term reduction in pain and quality of life improvement for treated patients. This will ultimately lead to a reduction or elimination in need for opioids for chronic back pain patients and address the critical opioid epidemic in the U.S.”

SpinalCyte’s Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts which would otherwise be disposed of, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

Russo Partners LLC
David Schull, 858-717-2310
david.schull@russopartnersllc.com
or
Ned Berkowitz, 646-942-5629
ned.berkowitz@russopartnersllc.com
or
SpinalCyte, LLC
info@spinalcyte.com

Life Spine Announces Tremendous Profit and Revenue Growth in the Third Quarter of 2018

October 23, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the company recognized an EBITDA growth rate of 124% in the third quarter of 2018 over the third quarter of 2017. This was driven by a sales growth of 47% in the same period led by significant growth to their micro-invasive portfolio.

“Our accelerated financial growth in 2018 is a direct result of our dedication to being the most innovative company in spine. We have remained focused on launching products that are designed with the intention of reducing surgical procedure time, reducing operating costs, and providing better patient outcomes. We are excited that so far 2018 has exceeded our growth expectations and looking forward to 2019 we know we will see continued success through both our existing portfolio and the groundbreaking product launches slated for the coming months,” said Omar Faruqi, Chief Financial Officer for Life Spine.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Anika Reports Third Quarter 2018 Financial Results

October 24, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the third quarter ended September 30, 2018, and provided an update on its business progress in the period.

“Anika delivered solid financial results in the third quarter, while continuing to take important steps to accelerate revenue growth in 2019 and beyond,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “We are encouraged by the continued advances we are making across our deep pipeline and diverse commercial portfolio. During the quarter, CINGAL end user demand in Canada and Europe remained strong, and we were pleased to add four new distribution partners to further expand our commercial reach in Europe, Asia and South America. Focused international expansion efforts enabled us to realize a 31% year-over-year increase in international Viscosupplement revenue while we continued to generate strong earnings and cash flow. As we prepare to discuss the pathway for U.S. regulatory approval for CINGAL with the U.S. Food and Drug Administration in the first quarter of 2019, we believe Anika is well-positioned to transform into a global commercial company increasingly capable of generating significant value for our patients and shareholders.”

Third Quarter Financial Results

  • Total revenue for the third quarter of 2018 was $26.8 million, compared to $27.2 million for the third quarter of 2017. The year-over-year decline was due primarily to the impact from the voluntary recall of HYALOFAST, HYALOGRAFT-C, and HYALOMATRIX announced in May 2018.
  • Global Viscosupplement revenue increased 2% year-over-year for the third quarter of 2018, while international Viscosupplement revenue increased 31% during the same period. The increases were primarily due to the growth of CINGAL in international markets, as well as the continued global expansion of Viscosupplement products overall.
  • Total operating expenses for the third quarter of 2018 were $18.2 million, compared to $16.9 million for the third quarter of 2017. The increase in total operating expenses was due primarily to higher production costs and increased personnel and professional costs.
  • Net income for the third quarter of 2018 increased to $7.6 million, or $0.53 per diluted share, compared to $6.9 million, or $0.46 per diluted share, for the third quarter of 2017. The increase in net income was due primarily to the reduction in R&D expenses as a result of the completion of the CINGAL 16-02 study and lower income tax expenses in 2018.

Recent Business Highlights

  • Continued to work with external regulatory and legal experts to seek regulatory approval of CINGAL in the U.S. market. Anika plans to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2019 and is developing multiple strategies to enable the company to move forward expeditiously once it has received guidance from the FDA regarding the pathway for CINGAL.
  • Advanced the Company’s product pipeline with the completion of preclinical development activities for its regenerative therapy for rotator cuff repair.
  • Strengthened Anika’s international product distribution network and expanded the Company’s commercial reach with four new distribution partners in Europe, Asia and South America.
  • Continued to evaluate potential partnership opportunities for the Company’s expansive product pipeline as part of the ongoing work on its 5-year strategic plan.
  • Convened an international distributor meeting at the Company’s European headquarters to align key growth objectives and market approach strategies for 2019.
  • Appointed Cheryl Blanchard, Ph.D., and Susan Vogt as new independent members of the Company’s Board of Directors.

Full Year 2018 Revised Corporate Outlook
Based on currently available information, the Company anticipates full year product revenue to be approximately 3% below prior year. The Company continues to expect that it will resume the shipment of products that were the subject of the previously-disclosed voluntary recall by the end of this year. Total operating expenses are now expected to be reduced to the high $80 million range for the full year of 2018 as a result of successful cost control initiatives.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights today, Wednesday, October 24 at 5:00 pm ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the Investor Relations section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements
The statements made in the last sentence of the second paragraph of this press release and in the Section captioned “Full Year 2018 Corporate Outlook,” which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s expected meeting with the U.S. Food and Drug Administration during the first quarter of 2019, the Company’s full-year 2018 product revenue and operating expense projections, and the Company’s expectations related to shipment of products previously subject to the voluntary recall. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
For the Three Months Ended September 30, For the Nine Months Ended September 30,
2018 2017 2018 2017
Product revenue $ 26,781 $ 27,178 $ 78,581 $ 78,899
Licensing, milestone and contract revenue 6 6 18 5,133
Total revenue 26,787 27,184 78,599 84,032
Operating expenses:
Cost of product revenue 8,282 6,250 24,279 18,648
Research and development 4,232 5,842 14,126 14,521
Selling, general and administrative 5,700 4,823 28,207 14,862
Total operating expenses 18,214 16,915 66,612 48,031
Income from operations 8,573 10,269 11,987 36,001
Interest and other income, net 522 261 907 335
Income before income taxes 9,095 10,530 12,894 36,336
Provision for income taxes 1,496 3,643 1,890 12,587
Net income $ 7,599 $ 6,887 $ 11,004 $ 23,749
Basic net income per share:
Net income $ 0.53 $ 0.47 $ 0.76 $ 1.63
Basic weighted average common shares outstanding 14,237 14,579 14,524 14,572
Diluted net income per share:
Net income $ 0.53 $ 0.46 $ 0.74 $ 1.58
Diluted weighted average common shares outstanding 14,377 15,115 14,820 15,065
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
ASSETS September 30,
2018
December 31,
2017
Current assets:
Cash, cash equivalents and investments $ 149,011 $ 157,256
Accounts receivable, net 20,771 23,825
Inventories, net 23,828 22,035
Prepaid expenses and other current assets 1,981 3,211
Total current assets 195,591 206,327
Property and equipment, net 55,041 56,183

Other long-term assets

1,109 1,254
Intangible assets, net 9,564 10,635
Goodwill 7,959 8,218
Total assets $ 269,264 $ 282,617
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 2,462 $ 6,747
Accrued expenses and other current liabilities 6,843 6,326
Total current liabilities 9,305 13,073
Other long-term liabilities 574 660
Deferred tax liability 4,120 5,393
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.01 par value
Common stock, $0.01 par value 142 147
Additional paid-in-capital 49,836 68,617
Accumulated other comprehensive loss (5,228 ) (4,784 )
Retained earnings 210,515 199,511
Total stockholders’ equity 255,265 263,491
Total liabilities and stockholders’ equity $ 269,264 $ 282,617
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data

Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)

For the Three Months Ended September 30, For the Nine Months Ended September 30,
Product Line: 2018 % 2017 % 2018 % 2017 %
Orthobiologics $ 24,097 90 % $ 23,990 88 % $ 69,778 88 % $ 68,686 87 %
Surgical 1,191 4 % 1,765 7 % 3,700 5 % 4,395 6 %
Dermal 80 1 % 358 1 % 163 1 % 1,235 2 %
Other 1,413 5 % 1,065 4 % 4,940 6 % 4,583 5 %
Product Revenue $ 26,781 100 % $ 27,178 100 % $ 78,581 100 % $ 78,899 100 %
Product Gross Profit $ 18,499 $ 20,928 $ 54,302 $ 60,251
Product Gross Margin 69% 77% 69% 76%

Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)

For the Three Months Ended September 30, For the Nine Months Ended September 30,
2018 % 2017 % 2018 % 2017 %
Geographic Region:
United States $ 21,695 81 % $ 22,227 82 % $ 63,377 81 % $ 63,507 81 %
Europe 3,132 12 % 2,832 10 % 9,021 11 % 9,743 12 %
Other 1,954 7 % 2,119 8 % 6,183 8 % 5,649 7 %
Product Revenue $ 26,781 100 % $ 27,178 100 % $ 78,581 100 % $ 78,899 100 %

Contacts

Anika Therapeutics, Inc.
Joseph Darling, 781-457-9000
President & CEO
or
Sylvia Cheung, 781-457-9000
CFO

Susan Vogt Appointed to Board of Directors of Anika Therapeutics

October 24, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK) (“Anika” or the “Company”), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, announced that, effective immediately, Anika’s Board of Directors has appointed Susan Vogt as an independent director.

Ms. Vogt most recently served as Chief Executive Officer and Director of Aushon Biosystems, a venture-backed company with a novel multiplex immunoassay platform. She previously served as President, CEO, and a Director of SeraCare Life Sciences, a publicly traded life sciences company focused on human diagnostics and therapeutics. From 2001 to 2005, she served as President of the Biopharmaceutical Division of Millipore Corporation (now MilliporeSigma), where she began her career in 1981. She earned a Master of Business Administration with high honors in Finance from Boston University, where she received a Distinguished Alumni Award in 2009, and a Bachelor of Arts degree from Brown University.

The Company also announced that Steven Wheeler, who has served as a director of Anika since 1993 and currently chairs the Board’s Governance and Nominating Committee, has notified the Board of his intention to retire as of February 8, 2019.

“This is another important step in the transition of Anika’s leadership that began with the appointment of Joseph Darling as CEO in March of this year,” said Joseph L. Bower, Chairman of the Board of Directors, “and it demonstrates our continued commitment to strong corporate governance and refreshment of the Board.”

“Sue brings to Anika more than thirty-five years of experience in the global life science research, pharmaceutical, biotech and clinical diagnostics industries, and we are excited she is joining our Board,” said Joseph G. Darling, President and CEO of Anika. “We are confident that Anika will benefit greatly from her input and guidance as we continue to advance our ongoing initiatives and enhance our global commercial reach.”

“Anika has a strong foundation with a deep pipeline and a diverse commercial portfolio, and I am excited to work with the other directors and management team to continue advancing the Company’s important work. I look forward to leveraging my experience as we continue to advance Anika’s clinical programs, deliver important therapeutic options for patients and drive profitable growth to enhance value for Anika shareholders,” Ms. Vogt said.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications, Inc.
Sonal Vasudev, 917-523-1418
sonal@w2ogroup.com

Ambulatory Surgery Center Market Report 2018 Focuses on Production, Consumption, Revenue (Million USD), Market Share and Growth Rate: Radiant Insights, Inc.

SAN FRANCISCOOctober 24, 2018 /PRNewswire/ —

The global ambulatory surgery center market is subject to witness a substantial growth over the forecast period due to the growing geriatric population, rising occurrence of chronic diseases, surging in healthcare costs, and recent technological advancements in the healthcare sector. However, absence of expertise and increase in number of reimbursement issues are restraining the market growth, in the recent years. Yet, recent technological advancements such as the development of big multi-service ambulatory care centers are expected to fuel the growth of ambulatory surgery center industry in upcoming years. Growing healthcare expenditure by developed economies across the globe are driving demand for the ambulatory surgery center, in the recent years. Ambulatory surgical center helps to solve several issues like treatment delay, absence of healthcare facilities, and higher cost. Lack of proper healthcare facilities particularly in rural areas of developing economies across the globe are anticipated to boost demand for ambulatory surgery center, thus providing lucrative growth opportunities for ambulatory care providers in near future. Increase in number of initiatives undertaken by local governments in collaboration with private bodies in both developing and developed economies to provide outpatient medical services in remote location where there is shortage of medical facilities, are expected to fuel the growth of ambulatory surgery center industry over the forecast period. Advent of improved pain operating methods in ambulatory surgery centers with the help of recent technological advancement that includes advanced surgical methodologies, anesthesia and enhanced drugs, are spurring market growth.

Other factors responsible for sustained the growth of ambulatory surgery center market are increase in the number of surgeries performed each year, substantial investment by private & public bodies, and reduced cost of clinical surgeries. Ambulatory care is termed as the process where surgical procedure is performed on a patient outside of the hospital premises or at remote locations. Ambulatory surgery center typically consists of all necessary medical facilities and surgical equipment that is required during operational procedures. Ambulatory surgery centers are well equipped with surgical equipment such as scalpels, scissors, saws, towel clamps, vascular clamps and more. Ambulatory surgery centers also contains life-supporting systems that are well organized to offer cost-effective medical services during critical situations. Limited healthcare facilities in rural area and growing patient pool are some of the critical factors driving the growth of ambulatory surgery centers industry in the last few years. Presence of ambulatory surgery centers in such scenarios aids in easing up the pressure on present medical facilities in the region. Lower cost associated with ambulatory surgery centers in comparison with the hospitals and nursing homes are predicted to amplify market expansion during the forecast period. The ambulatory surgery center industry is broadly divided into two categories such as hospital-based ambulatory surgery centers and freestanding ambulatory surgery centers. Hospital-based ambulatory surgery center is considered as one of the fastest growing segment in the ambulatory surgery center market with substantial revenue generation in the last couple of years. Ambulatory surgery center is capable of performing various surgical treatments such as laceration treatment, bone fracture treatment, emergency care service, and trauma or accident treatment.

The ambulatory surgery center industry is divided by region as North AmericaEuropeAsia-PacificLatin America and AfricaNorth America has shown major growth in recent years owing to the rise in the adoption of latest technologies in medicine & pharmaceutical sector and existence of well-established healthcare infrastructure. Other factors driving North America market include rise in the number of advanced diagnostic methodologies and increase in prevalence of orthopedics, ophthalmology, gastroenterology, plastic surgery, and chronic pain. Asia-Pacific region is predicted to hold major market share in the ambulatory surgery center industry with massive growth in forecast period. Countries such as IndiaChina and Singapore are leading the Asia-Pacific market with increase in the occurrence of angle closure glaucoma & myopia, longer in life expectancy, recent infrastructural activities such as development of emergency care centers outside conventional hospital settings, and significant investment by leading industry players considering potential growth opportunities in the region. The key players in the ambulatory surgery center industry are Surgery Partners, Inc., Envision Healthcare Co., IntegraMed America Incorporations, Symbion Incorporations, Terveystalo Co., NueHealth LLC, Aspen Healthcare Ltd., and Medical Facilities Co.

Access 115 page research report with TOC on Ambulatory Surgery Center Market available with Radiant Insights, Inc. @ https://www.radiantinsights.com/research/global-ambulatory-surgery-center-industry-2018

In this report, the global Ambulatory Surgery Center market is valued at USD XX million in 2017 and is expected to reach USD XX million by the end of 2025, growing at a CAGR of XX% between 2017 and 2025.

  • Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), market share and growth rate of Ambulatory Surgery Center in these regions, from 2013 to 2025 (forecast), covering
  • North America
  • Europe
  • China
  • Japan
  • Southeast Asia
  • India
  • Global Ambulatory Surgery Center market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer; the top players including
  • AmSurg
  • THC
  • HCA Healthcare
  • Mednax
  • Team Health
  • Surgical Care Affiliates
  • QHC
  • Surgery Partners
  • Medical Facilities
  • NOVENA
  • Community
  • Terveystalo Healthcare
  • SurgCenter Development
  • Elmhurst
  • Healthway Medical
  • SCH
  • Eifelhoehen-Klinik
  • On the basis of product, this report displays the production, revenue, price, market share and growth rate of each type, primarily split into
  • Single-specialty Centers
  • Multi-specialty Centers
  • On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including
  • Gastroenterology
  • Ophthalmology
  • Pain Management
  • Orthopedics
  • Others

Browse reports of similar category available with Radiant Insights, Inc.:

About Radiant Insights, Inc.:

At Radiant Insights, we work with the aim to reach the highest levels of customer satisfaction. Our representatives strive to understand diverse client requirements and cater to the same with the most innovative and functional solutions.

Contact:
Michelle Thoras.
Corporate Sales Specialist
Radiant Insights, Inc.
Phone: +1-415-349-0054
Toll Free: 1-888-928-9744
Email: sales@radiantinsights.com

Web: https://www.radiantinsights.com

SOURCE Radiant Insights, Inc.

Stryker completes acquisition of Invuity, Inc.

Kalamazoo, Michigan – October 23, 2018 – Stryker (NYSE:SYK) announced today the completion of its previously announced acquisition of Invuity, Inc.  Invuity is the leader in advanced photonics and single-use, lighted instruments that deliver enhanced visualization for a wide variety of clinical applications including orthopaedic and spine surgery, general surgery and women’s health procedures, and is a recent entrant into the enhanced energy market. Under the terms of the transaction, each outstanding share of Invuity common stock has been converted into the right to receive $7.40 in cash, without interest, subject to any required withholding taxes.

As indicated in the September 11, 2018 press release, the transaction is expected to have an immaterial impact to net earnings in 2018.

Forward-looking statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Such risk and uncertainties include, but are not limited to: unexpected charges or expenses in connection with the acquisition; weakening of economic conditions that could adversely affect the level of demand for Invuity’s products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for Invuity’s products; our ability to integrate acquisitions, including the acquisition of Invuity; our ability to realize anticipated cost savings or achieve other anticipated financial metrics in connection with the acquisition of Invuity; and the other factors identified under the heading “Risk Factors” in the Stryker Annual Report on Form 10-K for the year ended December 31, 2017 and our subsequent reports on Form 10-Q, all of which are filed with the Securities and Exchange Commission (SEC).

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Contacts

For investor inquiries please contact:
Katherine A. Owen, Stryker, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:
Yin Becker, Stryker, 269-385-2600 or yin.becker@stryker.com

Clinical Study Shows DJO’s “Dual-Pivot” Knee Replacement Technology Reduces Patient Dissatisfaction, Improves Function and Activity Levels

October 23, 2018

AUSTIN, Texas–(BUSINESS WIRE)–DJO (“DJO” or the “Company”), a leading provider of medical technologies designed to get and keep people moving, released a new clinical study to show that EMPOWR 3D Knee technology reduces patient dissatisfaction, and improves function and activity levels. Based on a multitude of studies on the biomechanics and kinematics of the knee joint, and more than 10 years of clinical heritage with DJO’s 3D Knee™, the EMPOWR 3D Knee® is the industry’s first “dual-pivot” technology, a breakthrough concept that is designed to better replicate the natural motion and feeling of the healthy knee.

With nearly 700,000 procedures performed in the U.S. each year, total knee replacement surgery (TKR) is one of the most widely accepted and effective treatments for relieving degenerative osteoarthritis pain and suffering. Unfortunately, nearly 20 percent of all patients – approximately 140,000 Americans each year1 – report they are not satisfied after their procedure, often claiming that their knee replacement “does not feel normal.”

EMPOWR 3D Knee® is one of the most functionally accurate prostheses ever created.1 EMPOWR 3D Knee®more closely recreates the natural dual-pivot motion pattern of the healthy knee throughout the entire range of motion, from early to deep flexion, creating a more natural feeling knee for the patient.1

Short term clinical results recently presented at the International Congress for Joint Reconstruction Hip and Knee Course in June 2018, demonstrate that the unique dual-pivot design of the EMPOWR 3D Knee® may offer far more natural motion for total knee arthroplasty (TKA) patients by more closely recreating the kinematics of a healthy human knee.2

The most significant clinical benefits of the EMPOWR 3D Knee® identified in the study include2:

  • Patient dissatisfaction is reduced by 50% compared to a competitive implant
  • Patient’s “knee feels normal” ~25% more often than with a competitive implant
  • Patients are over ~2X more active following surgery with the EMPOWR 3D Knee® versus a competitive knee implant

“Initial clinical results have been very encouraging for the EMPOWR 3D Knee®,” said presenter Dr. Michael Meneghini, MD, Associate Professor of Orthopedic Surgery at Indiana University School of Medicine. “Patients with the EMPOWR 3D dual-pivot knee implant are experiencing improved knee function and showing a greater likelihood of a normal feeling knee.”2

Dr. Scott Banks, PhD, Professor of Orthopedic and Joint Mechanics at the University of Florida, and Dr. Meneghini recently published an article in the journal Techniques in Orthopedics comparing the EMPOWR 3D Knee® implant to traditional knee implant designs. They concluded that contemporary dual-pivot design and kinematics of the EMPOWR 3D Knee® may contribute to improved function and satisfaction after TKR.1

“Clinical studies over the past decade have shown that healthy knees have a much more complex front-to-back and side-to-side motion than previously believed,” said Banks. “As a result, we now better understand why traditional knee arthroplasty designs have failed to accurately replicate normal knee activity and results in many patients feeling dissatisfied with their knee implant.”

“EMPOWR 3D Knee® patients tell us, ‘this knee just feels like my own,’ and that’s the whole point,” said Jeffery A. McCaulley, Global President of DJO Surgical®. “EMPOWR 3D Knee® goes beyond clinical effectiveness to deliver one of the most functionally accurate knee implants based on our novel dual-pivot design that helps to improve patient outcomes and patient satisfaction.”

For more information on the EMPOWR 3D Knee®, please visit: www.djoglobal.com/empowr.

1. Banks, Scott A., and Robert M. Meneghini. “Achieving More Natural Motion, Stability, and Function With a Dual-Pivot ACL-substituting Total Knee Arthroplasty Design.” Techniques in Orthopaedics 33, no. 1 (2018): 48-51.

2. “Replicating Native Knee Dual-Pivot Kinematics Improves Outcomes After Total Knee Arthroplasty” R. Michael Meneghini MD – ICJR South Presentation June 2018.

R. Michael Meneghini, MD is a consultant for DJO Global®.

Scott A. Banks, MD is a consultant for DJO Global®.

About DJO®

DJO® is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals.

In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga®, CMF™, Compex®, DonJoy®, ProCare®, DJO Surgical®, Dr. Comfort® and Exos®. For additional information on the Company, please visit www.DJOGlobal.com.

Contacts

DJO Media Contact:
Ashley Brown
Marketing Communications Manager
512.348.9098
ashley.brown@djoglobal.com
or
DJO Investor Contact:
David Smith
SVP, Treasurer and Investor Relations
760.734.3075
IR@djoglobal.com

Regentis Biomaterials Expands SAGE Clinical Trial of GelrinC™ for Knee Pain

October 23, 2018

PRINCETON, N.J. & OR AKIVA, Israel–(BUSINESS WIRE)–Regentis Biomaterials today announced it has expanded the SAGE clinical trial of GelrinC™ for the treatment of articular cartilage damage in the knee to 11 U.S. sites. GelrinC is an investigational device being evaluated as a treatment to help the body regrow cartilage in the knee.

Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Damage to the cartilage layer can be extremely painful for patients and is generally associated with sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care is called microfracture, which involves drilling small holes in the underlying bone to allow a blood clot to form within the defect. However, microfracture often provides only short-term relief and may require repeat surgeries.

“Cartilage repair is the largest unmet need in orthopedic sports medicine today,” said Alastair Clemow, Ph.D., president and CEO, Regentis Biomaterials. “GelrinC enables patients to harness the benefits of their own stem cells to promote cartilage regeneration in a single, minimally invasive procedure.”

People with knee pain caused by damaged articular cartilage who would like to be considered for the study can inquire by visiting www.MyKneeStudy.com or by calling (833) 430-8686.

The following orthopedic centers are currently or will soon be recruiting patients, with additional sites to be added soon in Denver, Colorado; San Francisco, California; Orlando, Florida; and Portland, Oregon.

  • RUSH University Medical Center (Chicago, Illinois)
  • Fort Lauderdale Orthopaedic Surgery & Sports Medicine (Fort Lauderdale, Florida)
  • Grossmont Orthopaedic Medical Group (San Diego, California)
  • Peninsula Orthopaedic Associates (Salisbury, Maryland)
  • Andrews Research & Education Foundation (Gulf Breeze, Florida)
  • Mansfield Orthopaedics (Morrisville, Vermont)
  • University Orthopedics Center (Altoona and State College, Pennsylvania)
  • TRIA Orthopaedic Center (Minneapolis, Minnesota)
  • The San Antonio Orthopaedics Group (San Antonio, Texas)
  • Optim Orthopedics (Savannah, Georgia)
  • Alpine Orthopedics (Bozeman, Montana)

About the SAGE Clinical Trial

The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. The multi-center Phase III pivotal study will enroll 120 patients. All patients who meet study requirements and agree to enter the trial are provided GelrinC as treatment, and their results will be compared to raw level historical data of a microfracture control arm. To be eligible for the study, participants must be between the ages of 18 and 50 and have pain caused by cartilage damage in only one knee. To learn more about the SAGE study, please visit www.GelrinC.com or call (833) 430-8686.

About GelrinC™

In the U.S., GelrinC™ from Regentis Biomaterials is an investigational device for patients with articular cartilage damage in their knee. GelrinC is composed of a synthetic material called polyethylene glycol (PEG) and a structurally modified form of human fibrinogen, a protein which in its native form assists healing processes. PEG and native human fibrinogen have been used individually in medical products for many years with excellent results. GelrinC’s unique mode of action relies upon its ability to be implanted as a liquid so that it completely fills the defect, and then be cured into a gel that enables the body’s own stem cells to settle on its surface. Over a period of six to 12 months, the GelrinC is gradually resorbed by the body and replaced by new cartilage tissue. Preliminary clinical trials in Europe have indicated that this regenerated tissue provides excellent improvement in pain and function. To learn more about GelrinC, please visit www.GelrinC.com.

About Regentis Biomaterials

With offices in Princeton, New Jersey, and Or Akiva, Israel, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The technology was originally developed at the Technion-Israel Institute of Technology by Dr. Dror Seliktar. For more information, please visit www.regentis.co.il.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez
323.532.0746
joni@merrymancommunications.com