MDT International

SportVis™ and RenehaVis™ in MIMS (UK)

Min Ng — 2012-04-16T16:46:50Z

MDT is proud to announce that both SportVis™ and RenehaVis™ are currently being on MIMS (UK) under section NEWS subsection NEW DRUGS.

SportVis™ and RenehaVis™ obtain Drug Tariff Listing in UK

Min Ng — 2012-04-16T15:37:17Z

The NHS Drug Tariff & Rules Team confirms that as of April 2012, both SportVis™ and RenehaVis™ will be included within Drug Tariff Part IX. - Announcements

Publication of RenehaVis long term data (104 weeks)

Min Ng — 2011-03-25T11:22:45Z

More information can be found at RenehaVis website under the studies section. - Announcements / renehavis

Long term efficacy and safety of a combined low and high molecular weight hyaluronic acid in the treatment of osteoarthritis of the knee

Min Ng — 2011-03-25T10:45:13Z

Abstract

Similar differences were observed for walking VAS 39, 41 and 43 (DMW, LMW, HMW) received repeat injections.

At 104 weeks, these differences were similar. DMW and LMW had no reported adverse events; HMW had 2 local reactions at 52 weeks and 1 at 104 weeks. There were no serious adverse events. Non- serious adverse events included pain and local swelling at the injection site (21%), erythema at the injection site (12%) and stiffness in the index knee (7%). Intra-articular hyaluronic acid injections using any of low, high or combined MW were highly effective in improving resting and moreso, walking pain in patients with osteoarthritis of the knee.

Greater improvement in both rest and activity outcomes in patients who received the DMW product, with concomitantly greater patient satisfaction and fewer use of concomitant therapeutic modalities at 16, 52 and 104 weeks suggest that combining a range of MW hyaluronic acid may be advantageous long term, particularly among active osteoarthriris patients.

Method

The primary objective of this study was to determine the efficacy and safety of intraarticular combined molecular weight hyaluronic acid in knee osteoarthritis as evaluated through the self-paced 40-m walking pain visual analog scale (VAS) at week 16, 52 and 104.

The secondary endpoints included: pain at rest. A 10 cm VAS, patient global satisfaction using a 5-point numerical scale, consumption of concomitant medications, number of patients with <45 mm pain at followup 52 and 104 weeks, and safety through the number of recorded adverse events. Patients received intra-articular injection once weekly for three weeks. Patients were followed up at week 16, 52 and 104.

Results

Greater improvement in patients who received the DMW product was achieved by the second injection and was persistent to 16 weeks.

At 52 weeks, 8 patients in DMW had VAS <45 mm and were not given repeat injections. At 104 weeks, 9 patients had VAS pain <45 mm in the DMW while all in the LMW or HMW groups was >45 mm.

DMW walking pain reduction was significantly greater than either of the LMW or HMW groups.

Again, those who received DMW had significantly greater walking pain reduction compared to the other 2 groups.

At 52 weeks, 8 patients in DMW group had resting VAS <45 mm. DMW had lower (62 mm, P<0.001) compared to LMW (76 mm) and HMW (88 mm) VAS at rest.

Global satisfaction was significantly higher for the DMW group compared to the other groups at 16, 52 and 104 weeks (P<0.005).

Patients in the DMW group had significantly greater improvement at 16, 52 and 104 weeks (P<0.001) compared to the other active treatment groups which did not differ from each other.

Further, fewer concomitant treatments (ie PT, acupuncture) were utilized by those who received DMW compared to the other treatments at all followup periods.

Similar trends in secondary outcomes were also observed at all time points. Combination of HA of lower and higher ranges of MW with low and high concentrations, may provide patients with a more physiologically dynamic HA viscosupplementation and hence a more responsive synovial rheology that improves pain and function in their osteoarthritic knee.

Conclusion

Greater improvement in patients who received the DMW product was achieved by the second injection persistent to 104 weeks.

Combination of Sodium Hyaluronate of lower and higher ranges of molecular weight with low and high concentrations, may provide patients with a more physiologically dynamic HA viscosupplementation and hence a more responsive synovial rheology that improves pain and function in their osteoarthritic knee.

The full clinical study can be found here.

ISSSMC 2010

Min Ng — 2010-08-25T10:17:39Z

MDT attended ISSSMC 2010 - International Sports Science + Sports Medicine Congress in Newcastle Upon Tyne (England) last week (19-21 August).

Both products, SportVis™ and RenehaVis™, were extremely well received by the physicians who attended.

Long-Term Efficacy And Safety Of A Combined Hyaluronic Acid In Osteoarthritis Of The Knee - POSTER PRESENTED AT EULAR 2010

Min Ng — 2010-07-20T15:43:24Z

The poster form of RenehaVis™ long term study was presented at EULAR 2010 in Rome. Please click on the document below to see a copy of this poster.

Management of Tennis Elbow with sodium hyaluronate periarticular injections

Min Ng — 2010-07-20T14:36:22Z

Management of Tennis Elbow with sodium hyaluronate periarticular injections

Robert J Petrella, Anthony Cogliano, Joseph Decaria, Naem Mohamed, Robert Lee
Dept Medicine, Canadian Centre for Activity and Aging, 801 Commissioners Road, London, N6C5J1, Canada

Abstract

Background:Chronic tennis elbow or lateral epicondylosis produces symptoms of pain and functional disability. Typical treatments include RICE for acute exacerbations as well as oral or topical NSAIDs, bracing and physical therapy. However, there is no consensus on treatment while efficacy of existing treatments is poor.

Intra-articular hyaluronic acid (HA) has shown efficacy equivalent to NSAID in the treatment of osteoarthritis while it's periarticular efficacy and safety have recently been reported for soft tissue use in acute ankle sprain. Hence, many patients, particularly those who require more rapid improvement to return to sport or work activity, or those in whom previous therapies have not achieved expected results, would benefit from a more rapid alleviation of symptoms, while still achieving the longer term benefits of hyaluronic acid that have been reported in other soft tissue indications.

Previous studies regarding treatment of chronic tennis elbow have shown lack of consensus as well as variable efficacy and high incidence of adverse effects. Hyaluronic acid has been used in soft tissue application for acute ankle sprain with high degree of efficacy and very limited side effect. Hence, given the biocompatibility of HA in treatment of acute ankle sprain we may show efficacy in terms of pain and function with low incidence of side effect and treatment of chronic tennis elbow.

Objectives: To determine the efficacy and safety of peri-articular hyaluronic acid injections in chronic lateral epicondylosis (tennis elbow).

Design: Prospective randomized clinical trial in primary care sport medicine.

Patients: Three hundred and thirty one consecutive competitive racquette sport athletes with chronic (>3 months) lateral epicondylosis were administered 2 injections (first injection at baseline) into the subcutaneous tissue and muscle 1 cm. from the lateral epicondyle toward the primary point of pain using a two-dimensional fanning technique. A second injection was administered 1 week later.

Outcomes measures: Assessments were done at baseline, days 7, 14, 30, 90 and 356. Efficacy measures included patient's visual analogue scale (VAS) of pain at rest (0-100 mm) and following assessment of grip strength (0-100 mm). Grip strength was determined using a jamar hydraulic hand dynamometer. Other assessments included patients' global assessment of elbow injury (5 point categorical scale; 1 = no disability, 5 = maximal disability), patients' assessment of normal function/activity (5 point categorical scale), patients/physician satisfaction assessment (10 point categorical scale), time to return to pain-free and disability-free sport and adverse events as per WHO definition. Differences between groups were determined using an intent-to-treat ANOVA.

Results: Average age of the study population was 49 years (± 12 years). One hundred and sixty-five patients were randomized to the HA and 166 were randomized to the control groups.
>The change in VAS pain was -6.7 (± 2.0) for HA vs -1.3 (± 1.5) for control (p < 0.001).
>The VAS post handgrip was -7.8 (± 1.3) vs +0.3 (± 2.0) (p < 0.001) which corresponded to a significant improvement in grip of 2.6 kg in the HA vs control groups (p < 0.01).
>Statistically significant improvement in patients' global assessment of elbow injury (p < 0.02), patients' assessment of normal function/activity (p < 0.05) and patients/physician satisfaction assessment (p < 0.05) were also observed favoring the HA group.
>Time to return to pain-free and disability-free sport was 18 (± 11) days in the HA group but was not achieved in the control group. VAS changes were maintained in the HA group at each followup while those in the control significantly declined from baseline.
>Assessment of patient and physician satisfaction continued to favor the HA group at subsequent followup.

Conclusion: Peri-articular HA treatment for tennis elbow was significantly better than control in improving pain at rest and after maximal grip testing. Further, HA treatment was highly satisfactory by patients and physicians and resulted in better return to pain free sport compared to control.

An online version of the published study can be found here

Information For Use

luc — 2010-07-20T14:29:48Z

SportVis™

To relieve pain and optimise recovery of the ankle following first or second degree sprain.

To relieve chronic pain and disability of the elbow with lateral epicondylalgia.

Presentation

SportVis™ is a clear solution of sterile 1% sodium hyaluronate in a phosphate buffered saline contained in a pre-filled syringe for:

• a series of two peri-articular injections into the soft tissue of the ankle; one peri-articular injection preferably within 48 hours of the injury and a second peri-articular injection 2 to 3 days following the first injection.

• a peri-articular injection in the elbow epicondyle followed by a second injection as may be required one week after the first injection.

Sodium hyaluronate is a long chain polysaccharide made up of repeating disaccharide units, which occurs naturally in the body.

SportVis™ has a pH and osmolality biocompatible with the soft tissue.

1.2ml of SportVis™, sterilised by filtration, is enclosed within a glass, ready to use, disposable syringe. The syringe is packed within a blister pack and an outer cardboard carton.

Dosage and Administration

Peri-articular injection of SportVis™ should only be made by a Healthcare Professional trained in the technique.

The dosage regimen is;

• one peri-articular injection preferably within 48 hours of the first or second degree ankle sprain and a second injection 2 to 3 days following the first injection.

• one peri-articular injection at the lateral elbow epicondyle site followed by a second injection at the same site one week after the first injection.

The contents of the syringe are sterile and should be injected using a sterile needle of an appropriate size (27 gauge needle is recommended).

The area to be treated should be disinfected before injection.

Ankle Sprains

Peri-articular injections should be delivered during a single penetration along the anterior talofibular ligament using clinical landmarks. The injection is delivered along 3 planes from antero-posterior, medial and lateral to the proximal ligamentous landmark.

1.2ml of SportVis™ is injected preferably within 48 hours of the injury and a second injection of 1.2ml is given 2 to 3 days after the first injection.

Lateral Epicondylalgia

Peri-articular injections - Identify the tenderest point of the epicondyle by gentle palpation.

Insert the needle at 90 degrees to the point of maximal pain on the lateral epicondyle. After insertion to the epicondyle, angle the needle at 45 degrees (or thereabout) and inject half the contents as the needle is withdrawn to the skin (without exiting the skin).

Insert the needle to 45 degrees in the opposite direction to the epicondylar point of maximum pain and inject the remaining contents on withdrawing of the needle outward. The needle is removed from the skin.

The elbow is flexed and extended five times and then internally and externally rotated five times

Discard the syringe and needle after single use.

Uses

SportVis™ is intended to relieve pain and optimise recovery of the ankle following first or second degree sprain.

SportVis™ is intended as well to relieve chronic pain and disability of the elbow after lateral epicondylalgia.

SportVis™ sodium hyaluronate augments the sodium hyaluronate naturally present in the soft tissue of the ankle joint thereby providing the ideal environment for healing of the damaged tissue.

Contra-indications

Patients with known sensitivity to sodium hyaluronate.

Warnings and Precautions

SportVis™ should only be injected by a healthcare professional trained in the procedure.

SportVis™ pre-filled syringes are single use. The contents of the syringe should be used for one injection only. Any remaining sodium hyaluronate should be discarded. If a syringe is retained for a subsequent injection there is a risk of contamination resulting in the possible infection of the patient and/or foreign body reaction.

SportVis™ must not be injected into blood vessels because sodium hyaluronate has the potential to occlude the vessels, which could result in embolism or infarction.

Do not inject into the soft tissue of patients if the area of the injection site is inflamed, infected or where there is evidence of acute or chronic skin disease.

Sodium hyaluronate is manufactured by fermentation of Streptococcus equi and rigorously purified. However, the healthcare professional should consider the immunological and other potential risks that can be associated with the injection of any biological material.

There is a risk of infection at the injection site as with any peri-articular procedure.

There is no evidence of the safety of SportVis™ in human pregnancy and lactation. Administration during pregnancy and lactation is at the discretion of the healthcare professional.

The safety and effectiveness of SportVis™ has not been tested for children. Administration to children below 18 is at the discretion of the healthcare professional.

SportVis™ should not be injected into a haematoma.

Needles should not be reused because SportVis™ may become turbid due to precipitation in the presence of cationic agents such as benzalkonium chloride or detergents residual in the needle following re-sterilisation.

Follow national or local guidelines for the safe use and disposal of needles. Obtain prompt medical attention if injury occurs.

Do not use if packaging has been damaged.

Adverse Reactions

Mild erythema that should resolve with time.

Incompatibilities

SportVis™ has not been tested for compatibility with other substances for peri-articular injection. Therefore the mixing or simultaneous administration with other peri-articular injectables is not recommended.

Storage

Store between 2°C and 25°C. Do not freeze. Protect from light.

Do not use if sterile packaging has been damaged.

Sterile product for single use only.

Do not use after expiry date.

Frequently Asked Questions

luc — 2010-07-20T13:35:33Z

Is there a time frame for the administration of SportVis™ for epicondylitis?

No. As epicondylitis is a chronic disease, SportVis™ can be administered anytime when the problem is presented to you.

The treatment is performed with 2 injections with an interval of 1 week. Why this is the optimum number for the treatment? What about doing more injections?

The clinical study results were obtained after 2 injections. We believe that the optimum results can be seen if the full therapeutic cycle is followed (that is, 2 injections with an interval of 1 week).

Additional administrations of SportVis™ during follow up assessments can be done, since SportVis™ contains STABHA™ (biocompatible Hyaluronic Acid).

Could you specify the place and way of injection?

Injections were be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique whereby contents were injected on withdrawal of the needle from the point of maximal tenderness in a single puncture.

Why is the fanning technique recommended for SportVis™ injection?

The fanning technique is essential to the administration of SportVis™ as it ensures a physical distribution of SportVis™ which allows larger surface area coverage of the soft tissue for maximum repair.

Can SportVis™ be mixed with other medicine like corticosteroids at injection?

No studies are available on mixing SportVis™ with other medicines therefore this would be dependent on the judgement and responsibility of the Healthcare professional.

Does SportVis™ replace the standard of care for epicondylitis?

SportVis™ was not created to replace the practise of standard care. It is advised that SportVis™ and standard of care should be used concomitantly.

Is SportVis™ listed on the doping list – that is, can I use it on my elite athletes?

SportVis™ is not listed as a doping agent and can be used on athletes of all standards.

How does SportVis™ work?

SportVis™'s main ingredient is STABHA™ (Soft Tissue Adapted Biocompatible Hyaluronic Acid).

Once STABHA™ is introduced to the site, it performs the following activities:
• It reacts with cellular fibronectin to create a scaffold which facilitates and controls the cellular migration at the injury site. This scaffold is able to promote healing as it acts as a barrier by limiting the access of macrophages and lymphocytes to this site.
• STABHA™is also helps in re-organising the fibrils in fibres and fascicles as well as restoring the fibres into their normal parallel arrangement.
• STABHA™ provides the injury site structural support as well as acts as a healing component.

STABHA™ which is contained in SportVis™ is believed to increase the quality of healing thus reducing scar tissue formation.

It was shown in the clinical study that patients using SportVis™ went back to their daily activities within a specific amount of time 18 (±11) days whereas this was not seen in the control group.

SportVis™ is an effective and efficient method of quantitative and qualitative management of epicondylitis. Results from using SportVis™ show that benefits have been seen even 1 year later.

What is the manufacturing process of SportVis™?

SportVis™ is produced by an innovative manufacturing process which is patented. SportVis™ is derived from continuous fermentation of Streptococcus equi.

After fermentation, the biomass is separated from the solution by filtration to obtain a cell-free solution. This solution is then purified by diafiltration to remove low molecular weight impurities (those derived from the production organism's metabolism, the residual components of the nutrient medium).

The precipitation of nucleic acids and endotoxins is obtained by the addition of a cationic surfactant.

This results in a purity profile that allows SportVis™ to be biocompatible with soft tissues.

What is the molecular weight of SportVis™?

Molecular weight is not the focal point of SportVis™ specific target. SportVis™ design was focused specifically using a very carefully selected set of parameters that gives the optimal rheological properties, thus residence time in the soft tissue.

Purity is also another key factor instead of molecular weight. Both the purity profile and ideal residence time in the soft tissue allows SportVis™ to achieve maximum interactions with torn ligaments and tendons.

Why SportVis™ volume is of 1.2 ml?

This is the studied optimal volume for ankle sprain recovery as this volume has shown to be the most efficient in this case. A larger volume is not used so as not create too much pressure at the injury site.

Where can I find SportVis™?

We have a network of distributors worldwide. Please contact the distributor from your region or you may also contact us.

Welcome to the healthcare professionals section

luc — 2010-07-20T09:37:00Z

In this section you will find information on the new product SportVis™ and its use in the treatment of epicondylitis. We have included SportVis™ prescribing information, clinical references, and other useful information.

If you require further assistance, please contact us.

Reduces Time to Recovery

A clinical study against placebo have shown that patients in the SportVis™ were able to return to sports within 18 (±11) days. This was not seen in the control group.
Clinical results:
Increased Grip Stregth


Increased Grip Strength

Lesser Pain when Gripping


Lesser Pain when Gripping

Lesser Pain at Rest


Lesser Pain at Rest

If you want to have more information, please click here

Improvement in the Quality of Healing

By interacting with the collagen fibres in the tendon, biocompatible SportVis™ facilitates the fibres into their normal parallel alignment for faster healing. SportVis™ also acts as a structural support and lubricant at the injury site to improve the healing process.

Manage Pain with a very low probability of Systemic Side Effects

Hyaluronic Acid, also known as sodium hyaluronate, has an ancillary effect of reducing pain. SportVis™ containing STABHA™ (Soft Tissue Adapted BIOCOMPATIBLE Hyaluronic Acid) will help reduce the pain in epicondylitis due to these ancillary effects with low probability of systemic side effects (none experienced during clinical trial and since the start of marketing globally).

Manage Pain and Swelling with very low probability of Systemic Side Effects

Sodium hyaluronate has an ancillary effect of reducing pain and limit inflammation. SportVis™ containing STABHA™ will help reduce the pain and limit inflammation in an ankle sprain due to these ancillary effects with low probability of systemic side effects (none experienced during clinical trials until now).

SportVis™ and Standard of Care

SportVis™ is a peri-articular injection


Injection for Epicondylitis

that can only be performed by a medical professional that has been trained in the injection technique. SportVis™ should be injected into the injury site and the 2nd injection to be administered 1 week after the 1st injection.

SportVis™ was designed to be used concomitantly with the standard of care - rest, ice and compression. Using SportVis™ together with the standard of care will allow the patient to regain rmobility and experience less pain faster.

How SportVis™ works?

SportVis™ containing STABHA™ (Soft Tissue Adapted
Biocompatible Hyaluronic Acid) has been designed specifically to interact optimally with soft tissue ligaments and tendons due to its purity profile and biocompatibility. When STABHA™ is injected into the site of injury, it reacts rapidly and efficiently with the microtears in the tendon. STABHA™ acts thanks to a dynamic supporting feature as it helps align the collagen fibres and restores the morphological and functional characteristic of the tendon structure. STABHA™ also helps by providing the ECM (Extra Cellular Matrix) with the required Hyaluronic Acid to aid in healing.

By saturating the injury site with STABHA™, the full potential of its supportive role is achieved.

About SportVis™

The main content of SportVis™ is STABHA™ (Soft Tissue Adapted
Biocompatible Hyaluronic Acid).

SportVis™ is a registered product with the CE mark and both SportVis™ and the manufacturing process for STABHA™ are patented.

SportVis™ is used for treating epicondylitis as well as grades 1 and 2 ankle sprains. It is administered via a peri-articular injection into the site of injury using the fanning technique. The fanning technique helps to spread SportVis™ over a large surface area within the injury site to have optimal interactions with the microtears in tendons and torn ligaments.