SOURCE: Lattice Biologics Ltd.

Lattice Biologics Ltd.

October 11, 2016 08:15 ET

Lattice Biologics Launches AmnioVisc™ All Natural Amniotic Fluid Supplement for Arthritic Joints

An Amniotic Fluid Based Viscosupplement for All Joints Demonstrates Lasting Pain Relief and Improved Outcomes in Clinical Study

SCOTTSDALE, AZ--(Marketwired - October 11, 2016) - Lattice Biologics Ltd. (TSX VENTURE: LBL) (OTCBB: BLVKF) ("Lattice Biologics" or the "Company") is pleased to announce the launch of AmnioVisc™, a minimally processed amniotic fluid supplement for the treatment of joint pain associated with osteoarthritis (OA). Armed with six months of excellent results from a 275-patient study to assess its efficacy and safety, AmnioVisc™ is the most studied amnio viscosupplement to date. The Western Institutional Review Board (WIRB) controlled study demonstrates lasting safe pain relief and fewer adverse events than the current standard of care Hyaluronic Acid (HA) viscosupplements on the market.

AmnioVisc™ is a novel, targeted regenerative therapeutic that is delivering promising relief for patients suffering from all degrees of OA pain. This product is anticipated to significantly accelerate the company's top line revenue growth.

(Read the study's monograph here.)

The Growing Osteoarthritis (OA) Problem
OA is the most common joint disorder in the United States.1 Approximately 10% of men and 13% of women aged 60 years or older demonstrate symptomatic knee OA.2 OA is the most common reason for total hip and total knee replacement.3 The number of people affected with OA is only expected to increase due to the aging of the population and the obesity epidemic.4 This already common disease is increasing rapidly, suggesting it will continue to have a growing impact on healthcare and public health systems into the future.5

Sometimes called degenerative joint disease or degenerative arthritis, osteoarthritis is the most common chronic condition of the joints, affecting approximately 27 million Americans. OA can affect any joint, but it occurs most often in knees, hips, lower back and neck, small joints of the fingers and the bases of the thumb and big toe.6

Relief for OA Sufferers
Healthy joints rely on synovial fluid for lubrication to allow bones to glide against one another. In addition to providing nourishment to the cartilage cells, healthy synovial fluid also lubricates the articulating bony structures of the joint during low impact movement and shock absorption during high impact activities.

Synovial fluid breaks down in people with osteoarthritis, contributing to joint pain and stiffness. At every stage of the osteoarthritic disease process, the deterioration of synovial fluid can be experienced by the patient as pain, stiffness, and reduced joint function. One of the treatments for OA is viscosupplementation (injection of a lubricating fluid -- which has most commonly been hyaluronic acid (HA) -- into a joint).

The purpose of viscosupplements is to replenish the body's naturally occurring synovial fluid with a substitute substance that recreates normal, healthy conditions as closely as possible and to break the cycle of synovial fluid deterioration. Viscosupplementation forms a protective layer around the inflamed articulating structures, covering micro-fractures and defects, and helping to restore the lubrication and protection of healthy synovial fluid.

Shortcomings in Current Therapies
Other osteoarthritis therapies currently available to patients offer inadequate relief and pose many serious side effects. Oral therapies (Acetaminophen, NSAIDs, COX II inhibitors, Duloxetine, and opioids) provide limited pain relief and present toxicity concerns to every part of the body, from the liver to the gastrointestinal and cardiovascular systems. Likewise, the pain relief benefits of intra-articular joint injections are similarly flawed, with the benefits of steroids disappearing after 2-4 weeks and the benefits of synthetic hyaluronic acid (HA) viscosupplements testing similar to placebo effects in controlled clinical studies.

As a result, the American Academy of Orthopedic Surgeons (2013) concluded that they "cannot recommend using Hyaluronic Acid for patients with symptomatic osteoarthritis of the knee."7 This conclusion was a strong recommendation and was based on a metaanalysis of studies that failed to show a clinically clinically significant benefit from synthetic viscosupplements.

Introducing AmnioVisc - Proven Amnio Viscosupplementation for Osteoarthritis
Lattice Biologics is excited to launch an amnio viscosupplement for all joints. AmnioVisc™ is a 100% natural, minimally processed amniotic fluid supplement for the treatment of joint pain associated with OA. In what is the largest study ever conducted on an amnio viscosupplement, this product clearly outperformed traditional standard of care HA-based viscosupplementation, including: single-injection MONOVISC™ (sodium hyaluronate in a phosphate buffered saline solution); and 3-injection ORTHOVISC® and Synvisc-One® (both mixtures made from rooster comb-sourced hyaluronan).8

By contrast, AmnioVisc™ (human amniotic fluid as a new source of viscosupplementation) was shown to reduce pain, stiffness and difficulty at statistically significant levels for patients with knee osteoarthritis in a protocol-driven, WIRB controlled Registry of 275 patients documented so far in this protocol-driven study.8

Using the total WOMAC pain score, patients who received our amnio viscosupplement experienced the following results:

  • At 30 days, 75% reported pain relief that was greater than 40%.
  • Impressively, at 90 days, the number of patients reporting greater than 40% relief increased to nearly 80%.
  • At 180 days (six months), two thirds of the patients (67%) were still reporting greater than 40% pain relief.
Study Efficacy Results8,9  Percent of Patients with greater than 40% Pain Improvement at 90 days (based on the total WOMAC pain score)
50%  ORTHOVISC®
62%  MONOVISC™
78%  AmnioVisc
    
Study Efficacy Results8,10  Average Pain Reduction over baseline at 6 Months (using the WOMAC scale)
33.8%  Synvisc-One®
54.1%  AmnioVisc

The AmnioVisc Advantage
There may be three reasons why Amniotic fluid is a more effective viscosupplement than either rooster comb derived HA or HA produced by fermentation technique:

  1. It is 100% human HA. Hyaluronan from human amniotic fluid is immune privileged as it lacks MHC antigens (so it does not elicit an inflammatory immune response).
  2. The components of amniotic fluid are very similar to healthy, native human synovial fluid. Both amniotic fluid and synovial fluid are ultrafiltrates from blood plasma and contain hyaluronan as well as phospholipids, cholesterol, growth factor proteins, cytokines and nearly the same inorganic compounds.
  3. It restores correct pH levels. Human amniotic fluid has a pH level of about 7.0; the same as healthy synovial fluid. Osteoarthritis tends to create an acidic, toxic environment in the knee that causes pH levels to fall, typically, to about 3.5. Human amniotic viscosupplementation restores healthy pH levels which, in turn, create conditions that allow the patient's own synovium to recover and -- potentially -- slow or even halt progression of the disease.

(Learn more about AmnioVisc here.)

About the Study - "Amnio-Viscosupplementation: Review of the Safety and Efficacy of Amniotic Fluid in the Management of Joint Pain in Osteoarthritis"
In a protocol driven, single arm post-marketing Registry approved by the Western Institutional Review Board (Olympia, WA), patients with Kellgren Lawrence Grade 1-3 OA via radiologic examination were treated with a single injection of processed donated human amniotic fluid. Eligible patients were injected with 4cc of AmnioVisc™ minimally processed amniotic fluid into the affected knee. The study utilized VAS scores and WOMAC overall and Pain, Stiffness and Difficulty (function) sub-score scales as the primary efficacy endpoints as measured during office visits at baseline and at 30, 90 and 180 days.

Read the study's monograph here.

Business Summary
AmnioVisc™ is currently patent pending and available for distribution throughout the United States, Canada, and internationally.

Learn More and Order AmnioVisc
Lattice Biologics Ltd. offers AmnioVisc in 0.5ml, 1.0ml, 2.0ml, 2.5ml, and 4.0ml sized doses.

To order AmnioVisc™, email: Clinicals@LatticeBiologics.com

For more information, call toll-free: 1-855-286-8088

Lattice Biologics Ltd.

Guy Cook,
Chief Executive Officer
Telephone No: (480) 563-0800

References:
1Felson DT, Lawrence RC, Dieppe PA, et al. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med. 2000;133(8):635-46.
2Burden of Musculoskeletal Diseases Bone and Joint Decade.
3DeFrances CJ, Podgornik MN. 2004 National Hospital Discharge Survey. Adv Data. 2006;371:1-19.
4Zhang Y, Jordan, JM. Clinics in Geriatric Medicine. August 2010 Volume 26, Issue 3: 355-369.
5Lawrence RC, Felson DT, Helmick CG, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008;58(1):26-35.
6http://www.arthritis.org/about-arthritis/types/osteoarthritis/what-is-osteoarthritis.php. October 03, 2016.
7The American Academy of Orthopaedic Surgeons Evidence-Based Guideline on Treatment of Osteoarthritis of the Knee, 2nd Edition. J Bone Joint Surg Am, 2013 Oct 16; 95 (20): 1885 -1886. http://dx.doi.org/
8Monograph: Amnio-Viscosupplementation: Review of the Safety and Efficacy of Amniotic Fluid in the Management of Joint Pain in Osteoarthritis. Liventa Bioscience. 2016.
9http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031c.pdf
10http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4404b1-09-FDA%20Executive%20Summary.pdf

About Lattice Biologics Ltd.
Lattice Biologics recently completed its RTO, becoming a publically traded company on January 4, 2016 and is traded on the TSX-V under the symbol: LBL. The Company is an emerging personalized/precision medicine leader in the field of cellular therapies and tissue engineering, with a focus on bone, skin, and cartilage regeneration.

Lattice Biologics develops and manufactures biologic products to domestic and international markets. Lattice's products are used in a variety of surgical applications.

Lattice Biologics maintains its headquarters, laboratory and manufacturing facilities in Scottsdale, Arizona as well as offices in Toronto Ontario. The facility includes ISO Class 1000 and ISO Class 100 clean rooms, and specialized equipment capable of crafting traditional allografts and precision specialty allografts for various clinical applications. The Lattice Biologics team includes highly trained tissue bank specialists, surgical technicians, certified sterile processing and distribution technicians, and CNC operators who maintain the highest standards of aseptic technique throughout each step of the manufacturing process. From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction.

Lattice Biologics maintains all necessary licensures to process and sell its tissue engineered products within the U.S. and internationally. This includes Certificates to Foreign Governments from the U.S. Food and Drug Administration (FDA) and registrations for 29 countries, which allow the export of bone, tendon, meniscus, ligament, soft tissue, and cartilage products outside of the U.S.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement on Forward-Looking Information
Certain information contained in this news release constitutes "forward-looking statements" within the meaning of the 'safe harbour' provisions of Canadian securities laws. All statements herein, other than statements of historical fact, are to be considered forward looking. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "potential", "future", "expected", "could", "possible", "goal", "intends", "will" or similar expressions. Forward-looking statements in this news release include, without limitation: information pertaining to the Company's strategy, plans, or future financial performance, such as statements with respect to future revenues or products, and other statements that express management's expectations or estimates of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Lattice to be materially different from those expressed or implied by such forward-looking statements.

Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by management as of the date such statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies. The factors and assumptions that could prove to be incorrect, include, but are not limited to: that market prices will be consistent with expectations, the continued availability of capital and financing, and that general economic, market and business conditions will be consistent with expectations. The forward-looking statements are not guarantees of future performance. We disclaim any obligation to update or revise any forward-looking statements, except as required by law. Readers are cautioned not to put undue reliance on these forward-looking statements.

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