AmnioVisc™ Allograft Amniotic Fluid Viscosupplement

LATTICE BIOLOGICS LAUNCHES AMNIOVISCTM
Targeted healing right where you need it

AmnioVisc™ is 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.

(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.

AmnioVisc™ clearly outperformed the traditional standard of care HA-based viscosupplementation products.

Shown to significantly reduce joint pain, stiffness and difficulty for osteoarthritis patients.

  • After 30 days, 75% of patients reported greater than 40% pain relief.
  • After 90 days, nearly 80% reported greater than 40% relief.
  • After 180 days, 67% of the patients still reported greater than 40% pain relief.

AmnioVisco patient results

How It Works

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.

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. Consult your physician about treatment for knee, elbow, shoulder, wrist, foot, ankle, and facet joints, as well as the cervical and lumbar spine.

To Order:

Clinicals@LatticeBiologics.com

Call for more information:
1-855-286-8088 (TOLL FREE)
Download AmnioVISC Brochure

As featured on Stockhouse.com and Orthopedics This Week

AmnioVisc™ in the News

Reintroducing AmnioVisc™

Preview the Presentation below or download it full-size: pdf AmnioVisc™ Pitch Deck


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

AmnioVisc™

Reintroducing AmnioVisc™
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To Order:

Clinicals@LatticeBiologics.com

Call for more information:
1-855-286-8088 (TOLL FREE)
Download AmnioVISC Brochure