Monday, August 29, 2016

News: KFx Awarded a Third Patent for Self-Punching Orthopedic Anchors - US 9,414,835

SAN DIEGO--()--KFx announced that it has been awarded a third patent (US 9,414,835 (‘835)) for self-punching or self-tapping orthopedic anchors that eliminate the need to drill a hole prior to insertion. US (‘835) is part of the family of patents that are the subject of KFx’s pending patent infringement suit against Arthrex, a Naples, Florida based company.

KFX awarded a third patent for self-punching orthopedic anchors - US 9,414,835.
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In April 2015 KFx announced that the United States Court of Appeals for the Federal Circuit reaffirmed their ruling upholding a judgment of the United States District Court for the Southern District of California that Arthrex infringed three valid KFx patents for double-row rotator cuff repair. The total judgment in favor of KFx amounted to over $35 million. In the April 2015 ruling the Appeals Court denied Arthrex’s petition for en banc rehearing and issued a mandate to enforce the judgment. Arthrex thereafter paid in excess of $35 million to KFx. In November 2015 KFx announced that a petition for writ of certiorari filed by Arthrex was denied by the Supreme Court of the United States.
Separately, Arthrex filed suit on July 31, 2015 versus KFx and Dr. Joe Tauro alleging various claims. KFx and Dr. Tauro denied the allegations. Previously KFx had announced that it considered the Arthrex lawsuit baseless. The Court agreed and promptly dismissed Arthrex’s claims. In addition, KFx asserted new counterclaims for patent infringement based on Arthrex's infringement of two KFx patents for self-punching orthopedic anchors that eliminate the need to drill a hole prior to insertion. The KFx counterclaims remain pending. A trial date has not yet been set.
“We are pleased to have the USPTO award the ‘835 patent to add to our family of self-punching or self-tapping anchors. This further supports our pending case versus Arthrex,” remarked Tate Scott, president and CEO of KFx.
KFx is represented by Knobbe Martens of Irvine, CA and COLE SCHOTZ P.C. of Hackensack, New Jersey in the matter.
Cooley LLP is General Counsel to KFx.
Headquartered in Solana Beach, Calif., KFx Medical was founded in 2003 to develop products for tissue fixation in a variety of orthopedic surgical procedures performed on the shoulder, knee, foot, and ankle. KFx provides simple systems for orthopedic surgeons focused on sports medicine.
The company is privately held — Investors include Alloy VenturesCharter Life SciencesArboretum VenturesMontreux Equity Partners, and MB Venture Partners.

Contacts

KFx Medical
W. Tate Scott, 619-742-2010

Published at BusinessWire

News: Life Spine Announces Initial Cases and Multiple Surgeries for SENTRY™ Lateral Plate System

August 26, 2016 10:00 AM Eastern Daylight Time
Image result for SENTRY™ Lateral Plate
HUNTLEY, Ill.--()--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 has successfully completed initial cases with the SENTRY Lateral Plate System. SENTRY is a revolutionary lateral plate that has a low profile, intuitive design with a cam locking mechanism which allows the system to provide visual, tactile and audible confirmation of final locking.

“The SENTRY Lateral Plate System is a key innovation and has changed the way I approach my MIS procedures. The slim profile and small size work seamlessly with my minimally invasive approach, allowing me to keep the incision site as small as possible”
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SENTRY rounds out Life Spine’s full procedural offering for eLIF lateral fusion which consists of the LONGBOW Expandable Spacer, CENTRIC®Expandable Retractor System, OSTEO-LINK® biologics, PLATEAU®-X Lateral Spacer System and an integrated full line neuromonitoring system.
“The SENTRY Lateral Plate System is a key innovation and has changed the way I approach my MIS procedures. The slim profile and small size work seamlessly with my minimally invasive approach, allowing me to keep the incision site as small as possible,” said Dr. Zeshan Hyder, Orthopedic Spine Surgeon at the Bone and Joint Specialists in Indiana. “I am also able to achieve the ideal amount of fixation without having to use percutaneous screws. Because of that, I am only creating one incision site instead of multiple.”
SENTRY is scheduled for full product release by the end of 2016.
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.
Life Spine is a registered trademark.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
847-884-6117

Published at BusinessWire

News: Tyber Medical Launches Lateral Plate

MORRISTOWN, N.J.Aug. 24, 2016 /PRNewswire/ -- Tyber Medical, a privately held company focused on developing innovative medical devices for private label opportunities and advancing the science of bioengineered surfaces, announces the commercial launch of their lateral plating system.

Tyber Medical is excited to announce a product portfolio expansion with a low profile lateral plate including an innovative fixation technology. Through the use of new and patented features, the implant provides three points of fixation in each vertebral body, eliminating some instrumentation required by other systems on the market while minimizing surgical steps. In addition, to reduce the possibility of neurologic deficit, the elegant design of the screw mates it flush with the surface of the plate when locked. The result is potentially the best fixation option available.
"The market for lateral access instruments and implants is one of the fastest growing segments. Companies that haven't already secured their share of the market will soon find it harder and harder to compete. This new lateral plating system, together with Tyber's lateral retractor and interbody product, creates one of the best lateral access systems available in the market today," said Steve Zeiger, Senior Director of Sales and Marketing at Tyber Medical.
According to multiple market research sources, the global market for minimally invasive surgery is forecast to grow faster than any other segment over the next 3 - 5 years. Further, in todays OR, the posterior lumbar business goes hand in hand with the lateral business. The launch of Tyber Medical's competitive lateral implant, complete with a lateral plating system, is very timely considering the inflection point the market is approaching where the utilization of other approaches to the lumbar spine is reported to be stabilizing or even shrinking.
About Tyber Medical:
Tyber Medical, LLC, Morristown, New Jersey, a rapid commercialization device company, is creating new pathways to regulatory approved bioengineered implants and instruments for orthopedic companies, large distributors, and hospital organizations. Tyber Medical designs and develops full class II orthopedic systems; verifies and validates those systems using a QSR and ISO 13485 certified quality system; and pursues and maintains both US (FDA 510k) and OUS (CE Mark) regulatory approvals. Current products include the opening osteotomy system, headless and headed compression screws, snap-off screws, cervical plating system, lateral retractor system and spinal interbody spacers featuring both standard sterile and non-sterile PEEK andTyPEEK®, a proprietary titanium plasma sprayed PEEK. The company is also developing BioTy™, a nanotopography surface modification which limits the adherence of bacteria to implants.  For more information, please visit www.tybermedical.com.
The TyWedge™ System and Spinal Interbody Spacers are made with PEEK-OPTIMA® from Invibio® Biomaterial Solutions.
Contact: 
Steve Zeiger 
89 Headquarters Plaza North, #1464 
Morristown, New Jersey 07960 
(866) 761-0933 

Published at PRNewsWire

Wednesday, August 24, 2016

News: SI-BONE, Inc. Announces Publication of Two-Year Results From a Prospective Multicenter Clinical Trial Showing Long-Term Clinical Benefits from SI Joint Fusion with the iFuse Implant System

Image result for si-boneImage result for si-bone
SAN JOSE, Calif., April 20, 2016 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® ("iFuse"), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of two-year results from SIFI (Sacroiliac Joint Fusion with iFuse Implant System) a prospective multicenter clinical trial of SI joint fusion. The trial included 172 subjects at 26 US centers and was published in The International Journal of Spine Surgery which is the official journal of the International Society for the Advancement of Spine Surgery (ISASS). The publication is titled Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-up from a Prospective Multicenter Trial and the lead author was Bradley Duhon, MD of the University of Colorado.i

Two-year results show marked improvements in SI joint pain, disability and quality of life achieved at 6 and 12 months were maintained to two years. Outcome assessments included an intent-to-treat primary success/failure composite endpoint at 6 months that consisted of a reduction from baseline VAS SI joint pain of at least 20 points, absence of device-related serious adverse events, absence of neurological worsening related to the sacral spine, and absence of surgical reintervention for SI joint pain. Secondary endpoints included success rates at other time points, improvement from baseline in VAS SI joint pain, ODI, SF-36 and EQ-5D scores. Success rates were 80.2% at 6 months and remained high at 79.9% at both the 12- and 24-month follow-up. Mean SI joint pain improved from 79.8 at baseline to 28.1 at 12 months and remained low at 26.0 at 24 months (see Figure 1). ODI decreased from 55.2 at baseline to 31.5 at 12 months and remained low at 30.9 at 24 months (see Figure 2). Quality of life improvements seen at 12 months were maintained at 24 months.
Figure 1 - VAS SI Joint Pain
 

Figure 2 - Oswestry Disability Index (ODI)
 

Furthermore, although the trial did not have the specific goal of opioid use reduction and patients were not required to participate in a structured drug reduction program, results showed a decrease in opioid use of 28% by month 24. Thirty-seven patients who were taking opioids at baseline had stopped taking them at month 24.
The surgical revision rate was low with 8 subjects having revision surgery (4.7%) and there were 7 device-related adverse events. Radiographic analysis was performed via CT scans at one year and showed a high rate of bony apposition to at least two implants on both the iliac and sacra sides with greater than 30% implant surface area coverage on each side of the SI joint.
"The target patient population and study eligibility criteria for SIFI were identical to INSITE, a prospective multicenter randomized controlled trial of iFuse vs. non-surgical management," said Dr. Danny Cher, Vice President of Clinical Affairs at SI-BONE. "INSITE showed superiority of iFuse compared to non-surgical management at nearly every endpoint at one year and SIFI at two years is an excellent proxy for INSITE two-year results which are expected to be published this summer."
Bradley Duhon, MD at the University of Colorado and lead author of the paper, commented, "Two-year results from the SIFI study further validate the long-term durability of the iFuse procedure and provide compelling, high quality evidence that early improvements in pain and disability are sustained to two years."  
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company develops, manufactures and markets minimally invasive products for the SI joint. SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010. 

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, and allow for biological fixation to support long-term fusion. The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
One or more of the individuals named herein may be past or present SI-BONE employees, consultants, investors, clinical trial investigators, or grant recipients. Research described herein may have been supported in whole or in part by SI-BONE.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9572.042016
Published at Si-Bone

Tuesday, August 23, 2016

News: Xtant™ Medical Reports Second Quarter 2016 Results

Second Quarter 2016 Highlights
  • Core recurring revenue (excluding OEM and other revenue) increased 5.6% to $20.9 million compared to core pro forma recurring revenue of$19.8 million in second quarter 2015 

  • Gross profit increased to $14.7 million, compared to pro forma second quarter 2015 gross profit of $14.0 million 

  • Gross margins improved to 68.5% compared to 64.9% for the second quarter of 2015 

  • The Company reported an EBITDA gain of $332,973 for the second quarter 2016

ELGRADE, Mont.Aug. 01, 2016 (GLOBE NEWSWIRE) -- Xtant™ Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medical devices, today reported its financial results for the three months ended June 30th, 2016. The Company reported quarterly revenues of approximately $21.5 million and an EBITDA gain of approximately $332,973.

Revenue
Second quarter 2016 revenue was approximately $21.5 million compared to pro forma revenue of approximately $21.6 million for the same period during 2015. Core recurring revenue, which excludes other revenue and revenue associated with Original Equipment Manufacturer (OEM) customers, increased 5.6 % to $20.9 million.
Stated in 000's2Q15*
 2Q16
      
Revenue$  21,622  $  21,462 
OEM & Other Revenue  $  1,857  $  586 
Core Revenue$  19,765  $  20,876 
Core Revenue Growth  5.60%
   
*Pro Forma Results

Gross Profit
Gross profit for the second quarter of 2016 was $14.7 million or 68.5% of revenue, compared to pro forma gross profit of$14.0 million or 64.9% of revenues for the second quarter of 2015.
Sales and Marketing Expenses
Second quarter 2016 sales and marketing expenses increased to $10.4 million, as compared to pro forma sales and marketing expenses of $9.3 million during the same period in 2015. For the quarter, sales and marketing as a percentage of revenues increased to 48.6%, compared to 43.1% in the second quarter of 2015, on a pro forma basis.The increase was mainly due to the higher OEM revenue in the second quarter of 2015 which has no associated sales commissions. In addition, as part of its growth strategy, the Company increased its sales infrastructure to support the portfolio selling opportunity of the combined business.
General and Administrative Expenses
In the second quarter, general and administrative expenses decreased slightly to $3.9 million compared to pro forma general and administrative expenses of $4.0 million, for the same period last year. As a percentage of revenue, general and administrative expenses were 18.2% during the period as compared to pro forma 18.3% for the same period during 2015.
Net Income / Loss
Second quarter 2016 consolidated net loss remained flat at $4.5 million, compared to the pro forma year-ago period.
EBITDA
The Company defines earnings before interest, taxes, depreciation and amortization ("EBITDA") as net income/loss from operations before depreciation, amortization, impairment charges, non-recurring expenses and non-cash stock-based compensation. Consolidated EBITDA for the second quarter of 2016 was a gain of $332,973 compared to an EBITDA loss of $144,749 for the first quarter of this year.
Financial Liquidity
Cash on hand as of June 30, 2016, was $2.2 million, as compared to $6.4 million as of December 31, 2015. This figure excludes cash resources available to be drawn down by the Company through its accounts receivable facility with Silicon Valley Bank and its equity credit facility with Aspire Capital.
Outlook for Full Year 2016
The Company decreased its full year 2016 revenue guidance based on the following:

**Non-GAAP profitability is defined as EBITDA less total cash based interest expense.
Conference Call to be Held August 2, 2016
An accompanying conference call will be hosted by Dan Goldberger, Chief Executive Officer, and John Gandolfo, Chief Financial Officer, to discuss the results. The call will be held at 10:00 AM ET, on August 2, 2016. Please refer to the information below for conference call dial-in information and webcast registration.
Conference date: August 2, 201610:00 AM ET 
Conference dial-in: 877-269-7756 
International dial-in: 201-689-7817 
Conference Call Name: Xtant Medical's Second Quarter 2016 Results Call 
Webcast Registration: Click Here
Following the live call, a replay will be available on the Company's website, www.xtantmedical.com, under "Investor Info."
*Use of Pro Forma Financial Information
On July 31, 2015Bacterin International Holdings, Inc. acquired all of the issued and outstanding stock of X-Spine Systems, Inc. and the combined company was renamed Xtant Medical Holdings, Inc. Except for the financial results for the three months ended June 30, 2016, the results presented are on a pro forma basis as if the two companies were combined for the periods shown. Certain pro forma adjustments have been made to reflect the impact of the purchase transaction, primarily consisting of amortization of intangible assets with determinable lives and interest expense on long-term debt. In addition, certain historical expenses, such as warrant expense and interest expense associated with debt that was immediately repaid, were eliminated from these pro-forma results. The pro forma information does not necessarily reflect the actual results of operations had the acquisition been consummated at the beginning of the fiscal reporting period indicated nor is it indicative of future operating results. The pro forma information does not include any adjustment for potential revenue enhancements, cost synergies or other operating efficiencies that could result from the acquisition.
Additional information regarding the business combination and its impact on the Company's financial position will be set forth in the Company's Form 10-Q for the quarter ended June 30, 2016, which will be filed with the Securities and Exchange Commission on or about August 8, 2016 and will include the Company's unaudited consolidated financial statements as of and for the quarters ended June 30, 2016 and June 30, 2015.
About Xtant™ Medical Holdings, Inc.
Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.
Important Cautions Regarding Forward-looking Statements
This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as "continue," "efforts," "expects," "anticipates," "intends," "plans," "believes," "estimates," "projects," "forecasts," "strategy," "will," "goal," "target," "prospects," "potential," "optimistic," "confident," "likely," "probable" or similar expressions or the negative thereof.
Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.
Additional risk factors are listed in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading "Risk Factors." You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.
More information can be found at Investor Xtantmedical
XTANT MEDICAL HOLDINGS, INC.
 Condensed Consolidated Statements of Operations
 Unaudited Actual and Proforma Results
         
  For the Three Months Ended June 30,  For the Six Months Ended June 30, 
  2016 Actual Unaudited  2015 Pro Forma  2016 Actual Unaudited  2015 Pro Forma 
             
  Amount  Amount  Amount  Amount 
 Orthopedic Product Sales$ 21,311,322   $ 21,438,329   $ 42,119,357   $ 42,885,947  
 Other  150,248     183,795     319,548     464,538  
 Total Revenue  21,461,570     21,622,124     42,438,905     43,350,485  
                 
 Cost of sales  6,758,071     7,588,523     13,635,338     15,351,544  
                 
 Gross Profit  14,703,499     14,033,601     28,803,567     27,998,941  
                 
 Operating Expenses               
 General and administrative  3,899,280     3,964,237     7,383,992     7,878,508  
 Sales and marketing  10,420,028     9,321,087     20,932,994     18,894,329  
 Research and development  783,897     784,455     1,683,472     1,826,359  
 Depreciation and amortization  1,216,696     1,264,357     2,425,030     2,638,838  
 Acquisition and Integration related expenses  450,756     0     752,529     0  
 Non-cash consulting  55,296     74,073     110,592     140,869  
 Total Operating Expenses  16,825,952     15,408,209     33,288,608     31,378,903  
                 
 Net Gain (Loss) from Operations  (2,122,453)    (1,374,608)    (4,485,041)    (3,379,962) 
                 
 Other Income (Expense)               
 Interest expense  (2,984,186)    (2,999,971)    (5,811,361)    (5,992,052) 
 Change in warrant derivative liability  477,639     (14,081)    496,329     (476,289) 
 Non-cash consideration associated with stock purchase agreement  0     0     0     (558,185) 
 Other income (expense)  166,426     (115,858)    (258,574)    (104,021) 
                 
 Total Other Income (Expense)  (2,340,121)    (3,129,910)    (5,573,606)    (7,130,547) 
                 
 Net Gain (Loss) from Operations Before Benefit (Provision) for Income Taxes    (4,462,575)    (4,504,518)    (10,058,647)    (10,510,509) 
                 
 Benefit (Provision) for Income Taxes               
 Current  0     29,312     0     54,244  
 Deferred  0     0     0     0  
                 
 Net Income (Loss)$ (4,462,575)  $ (4,533,830)  $ (10,058,647)  $ (10,564,753) 
                 
 Net Income (loss) per share:         
 Basic$ (0.37)  $ (0.64)  $ (0.84)  $ (1.53) 
 Dilutive$ (0.37)  $ (0.64)  $ (0.84)  $ (1.53) 
                 
 Shares used in the computation:         
 Basic  12,101,356     7,137,391     11,999,478     6,914,698  
 Dilutive  12,101,356     7,137,391     11,999,478     6,914,698