Mr. Guy Cook reports

LATTICE BIOLOGICS LAUNCHES AMNIOVISC ALL NATURAL AMNIOTIC FLUID SUPPLEMENT FOR ARTHRITIC JOINTS

Lattice Biologics Ltd. has launched 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 WIRB (Western Institutional Review Board)-controlled study demonstrates lasting safe pain relief and fewer adverse events than the current standard of care hyaluronic acid viscosupplements on the market.

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

The growing osteoarthritis problem

Osteoarthritis is the most common joint disorder in the United States. Approximately 10 per cent of men and 13 per cent of women aged 60 years or older demonstrate symptomatic knee osteoarthritis. Osteoarthritis is the most common reason for total hip and total knee replacement. The number of people affected with osteoarthritis is only expected to increase due to the aging of the population and the obesity epidemic. This already-common disease is increasing rapidly, suggesting it will continue to have a growing impact on health care and public health systems into the future.

Sometimes called degenerative joint disease or degenerative arthritis, osteoarthritis is the most common chronic condition of the joints, affecting approximately 27 million Americans. Osteoarthritis 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.

Relief for osteoarthritis 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 osteoarthritis 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 osteoarthritis is viscosupplementation (injection of a lubricating fluid, which has most commonly been hyaluronic acid, 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 two to four weeks and the benefits of synthetic hyaluronic acid viscosupplements testing similar to placebo effects in controlled clinical studies.

As a result, the American Academy of Orthopedic Surgeons (2013) concluded that it cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee.

This conclusion was a strong recommendation and was based on a meta-analysis of studies that failed to show a clinically significant benefit from synthetic viscosupplements.

Introducing AmnioVisc -- proven amnio viscosupplementation for osteoarthritis

AmnioVisc is a 100-per-cent-natural, minimally processed amniotic fluid supplement for the treatment of joint pain associated with osteoarthritis. In what is the largest study ever conducted on an amnio-viscosupplement, this product clearly outperformed traditional standard of care hyaluronic acid-based viscosupplementation, including single-injection Monovisc (sodium hyaluronate in a phosphate-buffered saline solution) and three-injection Orthovisc and Synvisc-One (both mixtures made from rooster comb-sourced hyaluronan).

In 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.

Using the total WOMAC pain score, patients who received the company's amnio-viscosupplement experienced the following results:

• At 30 days, 75 per cent reported pain relief that was greater than 40 per cent.
• Impressively, at 90 days, the number of patients reporting greater than 40-per-cent relief increased to nearly 80 per cent.
• At 180 days (six months), two-thirds of the patients (67 per cent) were still reporting greater than 40-per-cent pain relief.

Study efficacy             Per cent of patients with greater than 
results                   40-per-cent pain improvement at 90 days 
                             (based on the total WOMAC pain score) 
                                         
50 per cent                                             Orthovisc                         
62 per cent                                              Monovisc  
78 per cent                                             AmnioVisc                          
                                                                            

Study efficacy               Average pain reduction over baseline
results                      at six months (using the WOMAC scale) 
                                                
33.8 per cent                                         Synvisc-One                         
54.1 per cent                                           AmnioVisc                         

The AmnioVisc advantage

There may be three reasons why amniotic fluid is a more effective viscosupplement than either rooster comb-derived hyaluronic acid or hyaluronic acid produced by fermentation technique.

1. It is 100 per cent human hyaluronic acid. 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 seven, 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 postmarketing registry approved by the WIRB, patients with Kellgren Lawrence grade 1 to grade 3 osteoarthritis via radiologic examination were treated with a single injection of processed, donated human amniotic fluid. Eligible patients were injected with four cubic centimetres of AmnioVisc minimally processed amniotic fluid into the affected knee. The study used VAS scores and WOMAC overall and pain, stiffness and difficulty (function) subscore scales as the primary efficacy end points as measured during office visits at baseline and at 30, 90 and 180 days.

Business summary

AmnioVisc is currently patent pending and available for distribution throughout the U.S., Canada and internationally.

We seek Safe Harbor.