Mark McClellan, Frank McStay, and Robert Saunders – August 30, 2016

As the largest change in Medicare physician payment since the Sustainable Growth Rate formula, the Medicare Access and CHIP Reauthorization Act (MACRA) will affect up to 836,000 clinicians and allocate more than $1.2 billion in payment bonuses and penalties in its first year alone. Reflecting the importance of this policy, the 962 page proposed rule for its implementation generated thousands more pages of comments, with nearly 4,000 organizations and individuals submitting formal comment letters to the Centers for Medicare and Medicaid Services (CMS).

The proposed rule has been summarized by CMS, and there have been several Health Affairs Blogposts on MACRA. A major focus of the proposed rule is on the two main pathways for physician payments: the Merit-Based Incentive Payment System (MIPS), which adjusts fee-for-service (FFS) payments based on a composite measure of quality and value, and alternative payment models (APMs) that move away from FFS payment. How these features of the legislation are implemented will have a major impact not only on clinician payment but also on further developments in health care organizations, the way that they deliver care, and potentially the cost of care.

In this post, we highlight several big-picture policy questions raised by the proposed rule. More details on these topics are included in our comment letter to CMS.

What Alternative Payment Models Will Be Available To Clinicians?

One of the law’s key goals is to encourage movement from the traditional fee-for-service payment system to alternative payment models (APMs) focused more directly at the patient and population level. As an incentive for this shift, MACRA provides a 5 percent bonus to providers who participate in “advanced” APMs. The legislation sets a bar that envisions most clinicians would not qualify without significant payment change — it requires eligible providers to bear more than “nominal” financial risk for the costs of care they provide, to use quality measures similar to MIPS, and to use electronic records to coordinate and improve care.

There are few existing Medicare APMs that meet these criteria. If implemented as proposed in the rule, less than 10 percent of eligible clinicians would be participating in an advanced APMs. Several of the advanced APMs are accountable care organization (ACO) models with significant downside risk on total cost of care, which effectively limits availability to large consolidated provider organizations with substantial financial capital. Another is the Comprehensive Primary Care Plus (CPC+) pilot, which will be available to only some primary care providers and may not be permanent. The original CPC model also still needs to demonstrate overall program cost savings and quality improvement to be expanded nationally.

Some new options for certain specialists have become available since the MACRA rule was published. CMS proposed a larger set of mandatory episode bundles for hospital-based procedures and conditions, which expands the initial joint replacement bundled payment pilot to bypass surgery as well as heart attack and hip fracture care. CMS noted that physicians who provide enough of their care in collaboration with hospitals implementing these bundles can also qualify for advanced APM status.

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INCLINE VILLAGE, Nev., Aug. 29, 2016 /PRNewswire/ — PDL BioPharma, Inc. (NASDAQ: PDLI) (PDL or the Company) today announced that PDL has received approximately $57.4 million in connection with the termination of PDL’s credit agreement with Paradigm Spine, LLC, which included a repayment of the full principal amount outstanding of $54.7 million as well as accrued interest and a prepayment fee.  In February 2014, PDL entered into a credit agreement with Paradigm Spine in which it made available up to $75.0 million of debt financing with a five-year term, and initially provided $50.0 million, net of fees. PDL subsequently provided an additional $4.0 million in October 2015 as part of an amendment to the credit agreement.

“We are pleased with the successful conclusion of our debt financing to Paradigm Spine and the return on investment it has generated for PDL. This marks the fifth matured investment of the 17 income generating asset transactions we have entered into since we began these efforts in mid-2012,” stated John P. McLaughlin, president and chief executive officer of PDL. “We congratulate Paradigm Spine on their commercial progress and thank them for the opportunity to partner with them by offering debt financing to support their commercialization efforts.”

About PDL BioPharma, Inc.

PDL seeks to acquire pharmaceutical products through equity investments and also provide growth capital and financing solutions to late-stage public and private healthcare companies, including immediate financial monetization of royalty streams to companies, academic institutions, and inventors. PDL has committed over $1.4 billion and funded approximately $1.1 billion in these investments to date. PDL evaluates its investments based on the quality of the income generating assets and potential returns on investment. PDL is currently focused on acquiring and managing income generating assets, and maximizing value for its stockholders.

The Company was formerly known as Protein Design Labs, Inc. and changed its name to PDL BioPharma, Inc. in 2006. PDL was founded in 1986 and is headquartered in Incline Village, Nevada. PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases for which it receives significant royalty revenue.

PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.

Logo – http://photos.prnewswire.com/prnh/20110822/SF55808LOGO

SOURCE PDL BioPharma, Inc.

RANCHO CORDOVA, Calif., Aug. 24, 2016 (GLOBE NEWSWIRE) — Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that the Company has converted a senior secured three year convertible debenture of $12.5 million of principal and $8.25 million of interest to 6,102,941 shares of its common stock. The conversion was effected in accordance with the previously announced purchase agreement entered into between Cesca Therapeutics and Boyalife USA, dated February 2, 2016. It releases Cesca from all security interest and liens previously placed against the Company’s assets and eliminates Boyalife’s entitlement to certain participation rights in, or consent rights over, potential future equity and debt financings.

As a result of the conversion, Boyalife’s total holding in the Company will increase to 6,838,235 shares, or 70% of shares outstanding. The Company’s Board of Directors will increase to seven members of which Boyalife will have the right to designate three.

“We are pleased to have been able to convert all of our outstanding debt to equity”, commented Robin Stracey, Cesca Therapeutics’ Chief Executive Officer. “It enhances our balance sheet and gives us much greater financial flexibility in determining how best to proceed with our clinical programs, including the FDA-approved Phase III pivotal trial for the evaluation of our SurgWerks™ platform for the treatment of patients with late-stage critical limb ischemia. Boyalife has been, and continues to be, a valuable strategic partner that remains committed to both our historical cord blood banking business and to our proprietary cell therapy programs. We look forward to working more closely with them in unlocking the full commercial potential of our Company and driving shareholder value”.

About Cesca Therapeutics Inc. 

Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics.  These include:

• The SurgWerks™ System(in development) – a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure  Kits  for use in regenerative stem cell therapy at the point-of-care for  vascular and orthopedic diseases.
• The CellWerks™ System(in development) – a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
• The AutoXpress® System(AXP^®) – a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
• The MarrowXpress™System (MXP™) – a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
• The BioArchive® System– an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
• Manual bag setsfor use in the processing and cryogenic storage of cord blood.

Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995    

This press release includes statements of future expectations and other forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change.  Forward-looking statements can often be identified by words such as “potential,” “continue,” “look forward to,” “will” and similar expressions and include, but are not limited to, statements regarding the conversion of outstanding debentures, the taking of certain actions with respect to the conversion of such debentures owned by Boyalife Investment, Inc. and the anticipated expansion of the board of directors and designation of directors by Boyalife Investment, Inc. These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption “Risk Factors” in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.  We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

Company Contact: Cesca Therapeutics Inc.

ir@cescatherapeutics.com

Investor Contact: The Ruth Group

Lee Roth / Tram Bui

646-536-7012 / 7035

lroth@theruthgroup.com / tbui@theruthgroup.com

BEDFORD, Mass.–(BUSINESS WIRE)– August 25, 2016

Anika Therapeutics, Inc. (ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that its Chief Financial Officer, Sylvia Cheung, will participate in the following upcoming investor conferences:

• Barrington Research Fall Investment Conference on Thursday, September 8, 2016. The conference consists of 1:1 meetings, and it is being held at the Four Seasons hotel in Chicago.
• Morgan Stanley Global Healthcare Conference on Monday, September 12, 2016. Ms. Cheung is scheduled to present at 5:25 pm ET. The conference is being held at the Grand Hyatt hotel in New York City.
• Rodman & Renshaw 18^th Annual Global Investment Conference on Tuesday, September 13, 2016. Ms. Cheung is scheduled to present at 2:35 pm ET. The conference is being held at the Lotte New York Palace hotel in New York City.

Live audio webcasts of the Morgan Stanley and Rodman & Renshaw presentations may be accessed via the “Investor Relations” section of Anika’s website at www.anikatherapeutics.com. Audio archives of the presentations also will be available on the website shortly after the conclusion of the conferences.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (ANIK) is a global, integrated orthopedic medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC^® and MONOVISC^®) and pipeline (CINGAL^® and HYALOFAST^® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160825005123/en/

Aug 22, 2016 – Sean Williams

This year, we’ve witnessed all three major U.S. stock market indexes hit new all-time highs, which is nothing short of amazing considering the year began with the worst two-week tumble in recorded history and culminated with all three major U.S. indexes losing at least 10% of their value through mid-February from the beginning of the year.

But the long-term lesson is simple: The buy-and-hold investor usually triumphs. Since 1950, we’ve borne witness to 35 stocks market corrections of at least 10%, when rounded to the nearest integer, and in each and every instance, we’ve watched as stock market corrections have been buried by economic growth and bull market rallies. Smart investors understand that stock valuations have a tendency to rise over time, which is why they’re always on the lookout for high-quality stocks.

Could this be the first $1 trillion company?

Still, the one psychological mark that continues to be elusive for investors is the $1 trillion valuation mark. You could arguably say the race is on to reach this lofty ceiling, with expected contenders like Apple and Alphabet, the parent company of Google, leading the way. But, don’t ignore healthcare conglomerate Johnson & Johnson (NYSE:JNJ), which currently finds itself among the 10 largest companies in the world with a market valuation of $328 billion as of Friday. If the cards fall in J&J’s favor, it could become the first company to add 12 zeroes behind its valuation.

How, you ask? There are three factors working in its favor.

1. Product inelasticity

Economic cycles are inevitable in the U.S. economy. Although upswings tends to last a bit longer than downswings when we’re talking about bull and bear markets, the U.S. economy has entered a recession, on average, about every six years since 1929. Johnson & Johnson, though, provides products that are considered inelastic, meaning whether the economy is running on all cylinders or struggling, it tends to generate a consistent amount of growth and cash flow. In plainer terms, it’s pretty close to recession-proof.

Think about this from another angle. The consumer can’t choose when they’re going to get sick, or what type of illness they’ll develop. That alone would imply that two of J&J’s three operating segments — pharmaceuticals and medical devices — should do well in a robust or recessionary economy. J&J’s consumer product segment is the only area where some weakness could be observed, but even here we’re talking about consumer health products like Band-Aids that tend to be mostly resistant to downward pricing and demand pressures.

A number of companies with larger current market valuations than J&J are more susceptible to recessions, which could allow Johnson & Johnson to close this valuation gap over time.

READ THE REST HERE

AUG 23, 2016 – Bruce Japsen

As Aetna AET -0.37% and UnitedHealth Group UNH -1.17% retreat next year from most public exchanges under the Affordable Care Act in the face of losses they say they can’t handle, a model is emerging in Florida that may be the answer to caring for patients and turning a profit.

Florida Blue, a Blue Cross and Blue Shield plan, is offering a diverse mix of products statewide on public exchanges. That is in sharp contrast to UnitedHealth and Aetna, two of the nation’s largest health insurers, which will leave public exchanges in most states–including Florida beginning in 2017.

“ Florida Blue offers every metal level ACA product in every county in the state , and we offer four different product networks to satisfy a full range of consumer needs, so the makeup of the plans our members have chosen is very mixed,” Florida Blue spokesman Paul Kluding said in an interview.

Florida Blue said it began to prepare for Obamacare patients and their expensive medical claims three years ago when the rollout of coverage was dogged by technical issues of the Healthcare.gov web site. Back then, Florida Blue opened 20 retail centers across the state to sign up residents and the investment paid off.

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CARLSBAD, Calif., Aug. 24, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, today announced the effectiveness of a one-for-twelve reverse stock split of its common stock. The reverse stock split will take effect at 5:00 pm Eastern Time on August 24, 2016 and the Company’s common stock will open for trading on The NASDAQ Global Select Market on August 25, 2016 on a post-split basis.

The reverse stock split is intended to increase the per share trading price of the Company’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Global Select Market. As a result of the reverse stock split, every twelve shares of the Company’s common stock issued and outstanding prior to the opening of trading on August 25, 2016 will be consolidated into one issued and outstanding share. No fractional shares are being issued in connection with the reverse stock split.  Stockholders who would otherwise hold a fractional share of common stock will receive a cash payment in lieu of such fractional share. In connection with the reverse stock split, there will be no change in the nominal par value per share of $0.0001.

Trading of the Company’s common stock on The NASDAQ Global Select Market will continue, on a split-adjusted basis, with the opening of the markets on Thursday, August 25, 2016, under the existing trading symbol “ATEC” but with a new CUSIP number 02081G 201. The reverse stock split reduces the number of shares of the Company’s common stock outstanding from approximately 102.5 million pre-reverse split shares to approximately 8.5 million post-reverse split shares.

The Company has retained its transfer agent, Computershare Trust Company, N.A. (“Computershare”), to act as its exchange agent for the reverse split. Computershare will provide stockholders of record as of the effective date of the reverse stock split a letter of transmittal providing instructions for the exchange of their physical certificates. Stockholders owning shares via a broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split.

The reverse stock split was approved within a range of one-for-four to one-for-twelve by the Company’s stockholders at the 2016 Annual Meeting of Stockholders held on August 18, 2016, and the specific ratio of one-for-twelve was approved by the Company’s Board of Directors. For more information regarding the reverse stock split, please refer to the Company’s definitive proxy statement filed with the Securities and Exchange Commission on Schedule 14-A on June 22, 2016.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc. (ATEC), is a global medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. and internationally via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the reverse stock split of the Company’s common stock and its intended purpose. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading “Risk Factors” contained in the Company’s annual report and quarterly reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company disclaims any obligation to update the information contained in this press release as new information becomes available.

Investor/Media Contact:
Christine Zedelmayer 
Investor Relations 
Alphatec Spine, Inc. 
(760) 494-6610
czedelmayer@alphatecspine.com

By Joe Carlson – August 25, 2016

Medtronic PLC on Thursday reported lower adjusted net income in the most recent quarter and reiterated sales expectations for the year.

The company’s adjusted profit amounted to $1.03 in diluted earnings per share, two cents above Wall Street forecasts. Revenue was nearly in line with what had been expected.

Analysts with Leerink Partners predicted that Medtronic’s stock performance would be affected by the generally high expectations among investors in the med-tech sector overall this quarter.

Investors on the earnings call Thursday asked about the timing of Medtronic’s announcement Tuesday that it had completed its $1.1 billion acquisition of HeartWare, whose high-end heart pumps treat advanced heart failure by helping pump blood through the body. The HeartWare deal was originally projected to close by October.

“We really felt that we were in a position where we were getting critical mass around our expertise in heart failure,” chief executive Omar Ishrak said. “Where HeartWare was positioned as a company, we felt that we could add immediate value … We felt that this was absolutely the right time.”

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Grand View Research – August 2016

The global spinal implants and spinal devices market is expected to reach over USD 19.54 billion by 2024 according to a new report by Grand View Research, Inc.

The key drivers of the market include the rising number of spinal injuries, increasing trend in the adoption of sedentary lifestyles, postural defects stemming from bad posture habits at work and while driving, and a large number of people suffering from obesity. In addition to the above, the introduction of the image-based spinal navigation technology, the evolution of titanium biologics, and the ongoing research on the genetically modified bone morphogenetic proteins are also expected to positively reinforce the market growth.

Moreover, the increase in the geriatric population base prone to spinal disorders due to the lack of proper diet and exercise and declining bone density are also expected to fuel the market expansion over the forecast period.

The rising cost of spinal implants and procedural costs are a major concern across the globe and this factor is identified as a large strain on the emerging and low-income economies. Therefore, the introduction of novel bone growth stimulators and the increasing adoption of Minimally-Invasive Surgeries (MIS) surgeries that are relatively less-expensive are expected to propel the usage of spinal implants and devices over the forecast period.

With favorable government initiatives being advanced and the increasing number of investments being made by various private organizations is providing the thrust to the R&D activities pertaining to new product development and new treatment methods.

For instance, the American Academy of Orthopedic Surgeons and the North American Spine Foundation, both contribute towards the growth of the spinal implants and devices market through R&D funding activities and training programs for physicians globally.

 To request a sample copy or view summary of this report, click the link below:
http://www.grandviewresearch.com/industry-analysis/spinal-implants-spinal-devices-market

Further key findings from the study suggest:

• In 2015, the spinal fusion devices segment accounted for the largest share of over 38% as these are the most commonly used devices for the treatment of various conditions, such as spine stenosis, spondylolisthesis, and scoliosis. However, the spinal biologics segment is expected to emerge as the fastest growing with a CAGR of 7% due to the growing usage of minimally invasive and non-invasive procedures.
• In 2015, North America held the largest share of the spinal implants and devices market accounting for nearly 63%. The presence of advanced healthcare facilities, strong reimbursement support, and a large number of people suffering with spinal disorders are some of the major factors accounting for this region’s dominance.
• Asia Pacific is expected to be the fastest growing market due to the proliferation of the latest medical technologies andthe development of low-cost implants coupled with the growing medical coverage and the increasing per capita disposable income. Moreover, the growing support from the government to expand the healthcare services in the untapped markets is also expected to propel the market growth in this region.
• Some key players operating in the market are Medtronic plc, Depuy Synthes, Inc., Stryker Corporation, NuVasive, Inc., Zimmer Biomet Holdings, Inc., Globus Medical, Inc., Orthofix International Holding N.V., and LDR Holding Corporation.

Grand View Research has segmented the global spinal implants and spinal devices market on the basis of product, technology, type of surgery, and type of procedure:

Global Spinal Implants and Devices Market Product Outlook, by Revenue (USD Billion, 2016 – 2024)

• Spinal Fusion devices
• Spinal biologics
• Vertebral compression fracture treatment devices
• Non-fusion devices
• Spinal bone growth stimulators

Global Spinal Implants And Devices Market Technology Outlook, By Revenue (USD Billion, 2016 – 2024)

• Fusion and fixation technology
• Vertebral compression fracture treatment
• Motion preservation technologies

Global Spinal Implants And Devices Market Type Of Surgery Outlook, By Revenue (USD Billion, 2016 – 2024)

• Open surgery
• Minimally invasive surgery

Global Spinal Implants And Spinal Market Procedure Type Outlook, By Revenue (USD Billion, 2016 – 2024)

• Discectomy
• Laminotomy
• Foraminotomy
• Facetectomy
• Corpectomy

Spinal Implants and Spinal Market Regional Outlook, by Revenue (USD Billion, 2016 – 2024)

• North America
  • U.S.
  • Canada
• Europe
  • UK
  • Germany
• Asia Pacific
  • Japan
  • China
• Latin America
  • Brazil
  • Mexico
• MEA
  • South Africa

WARSAW, Ind., Aug. 23, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the third quarter of 2016.

The cash dividend of $0.24 per share will be paid on or about October 28, 2016 to stockholders of record as of the close of business on September 23, 2016.  Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

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SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com