Posted in Health Reform Watch | Sept., 2016 – Carolyn LaWell is ORTHOWORLD’s Chief Content Officer

To thrive in the healthcare environment of tomorrow, orthopaedic device companies will need to operate within a greater portion of the supply chain, assisting upstream and downstream customers in finding operational value. This will require companies to forge stronger relationships, focus on internal efficiencies and launch services, not just devices. Ultimately, the business models of orthopaedic device companies must radically change if they want to maintain profitability, margins and independence in coming years. This was the message from OMTEC® 2016 keynote speaker Bill Tribe, Ph.D., Partner at A.T. Kearney’s Health Practice.

The message is bold, yet not surprising. One needs to look no further than the product—not device, but product—launches of the largest industry players in recent years. Observe a number of examples: DePuy Synthes’ focus on bundled payment services,Stryker’s purchase and subsequent launch of the Mako robot, Smith & Nephew’s development of Syncera. Additional players and offerings, like Cardinal Health’s expansion into the commercialization of orthopaedic implants and Millstone Medical Outsourcing’s direct-to-patient and hospital distribution model, are reaching new portions of the supply chain.

Tribe referred to these as pilot programs. While it can be assumed that a large amount of research and resources, both personnel and capital, went into the creation of these technologies and services to gain meaningful return on their investments, most on this list are too early in their lifecycles to deem successful long-term.

What these companies attempt to do with these models, though, is to solve a different problem for their customers while generating a new revenue stream for themselves. They move beyond legacy devices and distribution to target new price points and customers, and even create new audiences. Tribe argued that all orthopaedic companies, regardless of size or position in the supply chain, should introduce alternative business models that match the shifts in healthcare and their own company needs.

Here is why.

The Economic Case

Margins across the medical device sector have been falling for more than a decade, and will continue to erode by about 5% if unaddressed, according to Tribe’s research. Compounding that is the continued negative impact of price pressure, at nearly 3% per year. An average orthopaedic company would need to reduce its cost of goods by 12% or its Selling, General and Administrative expenses by 8%, or some combination of the two, to offset that 3% in price pressure, he says. That pressure is consistent; therefore, companies must get leaner each year.

On a positive note, orthopaedics is a $46 billion industry growing in the low-single-digits year over year, according to ORTHOWORLD’s THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. Healthy procedural volumes due to a growing and aging population, and untapped and underserved markets, mean that the industry remains attractive.

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September 16, 2016

16 September 2016

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, is proud to announce that it has retained its position as an index component on the Dow Jones Sustainability Indices (DJSI).

Since 1999, the DJSI tracks the financial performance of the leading sustainability-driven companies worldwide based on an analysis of financially relevant economic, environmental, and social factors. Smith & Nephew is included in both the 2016 DJSI World and DJSI Europe Indices. Smith & Nephew has now been a member of DJSI World since 2002 and a member of DJSI Europe since 2001.

In the Healthcare Equipment and Supplies sector, Smith & Nephew is one of only seven members of the DJSI World Index and one of just three members for DJSI Europe. Smith & Nephew scored highly in Climate Strategy, Occupational Health and Safety, Social Reporting and was awarded a perfect score in the Environmental Reporting category, illustrating the company’s continued excellence in sustainable operations.

Olivier Bohuon, Chief Executive Officer of Smith & Nephew, said:

“We are firmly committed to making a meaningful contribution across all three pillars of sustainability – social, environmental and economic. Our emphasis is on delivering positive outcomes that advance the long-term prospects for our business everywhere we operate. We will continue to strive to be a responsible business that sets an example for others. ”

Media

Charles Reynolds, Corporate Communications
Smith & Nephew
+44 (0)20 7401 7646

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management,Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

_{Forward-looking Statements}

_{This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.}  

WALTHAM, Mass., Sept. 16, 2016 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that it has entered into a definitive securities purchase agreement to raise approximately $30.0 million in a private placement of common stock, Series A Convertible Preferred Stock and warrants exercisable for common stock.  The private placement is being led by new healthcare dedicated institutional investors, with participation by certain existing investors.

Histogenics expects to use the net proceeds from the private placement to support the development of NeoCart^®, its novel cartilage repair therapy, including the completion of the ongoing Phase 3 clinical trial, and for general corporate and working capital purposes.  Upon the closing of the private placement, Histogenics expects the proceeds raised in the offering along with its existing cash resources to last through the middle of 2018.  Based on Histogenics’ current plans, enrollment in the NeoCart Phase 3 clinical trial will be completed in the second quarter of 2017, with topline data on its 1-year primary efficacy endpoint available by the middle of 2018.

Pursuant to the terms of the securities purchase agreement, Histogenics has agreed to sell 2,653,553 shares of common stock at a price of $2.25 per share and 24,158.8688 shares of newly created Series A Convertible Preferred Stock, which shares of preferred stock are convertible into approximately 10,679,781 shares of common stock.  Purchasers will receive warrants to purchase up to approximately 13,333,334 shares of common stock at an exercise price of $2.25 per share.  The warrants will be exercisable following approval of the private placement byHistogenics stockholders and will expire 5 years from the date of such stockholder approval.  The closing of the offering is subject to the satisfaction of customary closing conditions.

Affiliates of certain members of Histogenics’ Board of Directors agreed to purchase an aggregate of 283,045 shares of common stock and 2,563.1451 shares of Series A Convertible Preferred Stock in the private placement and will receive warrants to purchase up to 1,422,221 shares of Histogenics’ common stock at an exercise price of $2.25 per share.

H.C. Wainwright & Co., LLC served as the sole placement agent in connection with this offering.

The securities to be sold in the private placement will not have been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United Statesabsent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements.  Histogenics has agreed to file one or more registration statements with the SECregistering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants and issuable upon conversion of the Series A Convertible Preferred Stock.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About Histogenics Corporation

Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace.  Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions.  Histogenics’ first investigational product candidate, NeoCart®, is currently in Phase 3 clinical development.  NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells.  Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year.  NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options.  For more information, please visit www.histogenics.com.

Forward –Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,”  “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others:  the expected closing and closing date of the offering and the use of proceeds of the offering and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, which are on file with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenicscautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Investor Relations

Tel: +1 (781) 547-7909

InvestorRelations@histogenics.com

Histogenics Corporation