Arthrosis, a disease that is constantly increasing and has a high social cost.Osteoarthritis (OA) is one of the most common chronic diseases and underestimated by those who do not suffer from it, characterised by intense pain with little tendency to resolve and consequent reduced mobility. Osteoarthritis (OA) affects about 250 million people worldwide and is the leading cause of disability in the US.
Studies have shown that the prevalence increases with age: 80 per cent of cases involve people aged 75 years and older[1]. The solution – to date – is mainly surgical: the only approved non-surgical products at present are steroids and hyaluronic acid, which effectively means that there are no drugs that can prevent, stop or halt the progression of OA. All this translates into a huge social cost: on average, adults with OA lose about 5.4 working days during the year, and about 3.5 million Americans are potential targets for prosthesis surgery each year. To date, the US market alone must account for health care expenditure of approximately $45.4 billion (2019 figure).
Globally, the size of arthrosis therapies has been estimated at around USD 7 billion in 2020, and is estimated to reach USD 16 billion by 2030, growing at a CAGR of 8.8% over the decade. Over the same period, the Asia Pacific region is expected to register a CAGR of 9.1 per cent, due to an increase in the prevalence of osteoarthritis, population growth, rising healthcare expenditure and lack of physical activity due to new lifestyles. The increasing ageing of the population and rising obesity rates are in fact conducive to OA: it is no coincidence that in the US – the largest market – the prevalence of symptomatic OA has increased in recent decades.
The global OA market therefore currently presents a number of unmet needs, primarily the lack of effective treatment options: most available pharmaceutical treatments provide only short-term benefits. Corticosteroids, for example, although effective in temporarily relieving joint symptoms, have been associated with cartilage deterioration, while other injectable options are limited by the lack of proven clinical trials, resulting in difficult access to reimbursement.
Furthermore, it must be emphasized that current therapies in use reduce pain and inflammation but cannot change the course of the disease or reverse the damage. Hence, there is a strong need for approaches that support the natural regeneration of damaged tissues by slowing down the progression of Osteoarthritis OA. This is a great need because, although total knee replacements are effective and durable, there is still a large segment of patients who require an improved quality of life without surgery or a segment of patients who cannot undergo surgery because they suffer from particular diseases.
[1]Source: Allied Market research report on Osteoarthritis, hopkinsarthritis.org, 10:1905-1915; Almatn et al 1986 Arthritis Rheum 29(8):1039,clinicaltrials.gov
Lipogems: the missing answer.
From mere symptom control, greater emphasis has therefore recently been placed on the development of new modalities in order to slow down disease progression. The state of the art to date counts oral analgesics/anti-inflammatories that only address the pain problem, intra-articular injections of corticosteroids that are effective in reducing pain in the short term and used when signs of inflammation arise, injections of hyaluronic acid with a joint lubricant and shock-absorbing function, and, finally, the use of regenerative medicine with reparative and anti-inflammatory functions, tested in a variety of animal models with potential tissue repair goals.
Lipogems International Spa, a company founded in Milan in 2012 from the idea of its two co-founders, internationally renowned plastic surgeon Dr. Carlo Tremolada and Professor Camillo Ricordi, director of the Diabetes Research Institute in Miami, one of the world’s leading experts in the treatment of diabetes, has inserted itself into this panorama of absolute need for effective innovations. The multinational company is active in 28 countries and has over 100 publications in peer reviewed journals.
Lipogems has identified and patented (8 patent families in 70 patents applied in the US, EU, Japan, Australia, China with focus on ‘Method and Device’ and its derivatives expiring in 2031) a new proprietary technology based on mesenchymal (adult stem) cells.
The solution involves the use of adipose tissue taken from the patient himself, which is micro-fragmented while keeping the cellular and tissue microarchitecture intact, supporting tissue repair over time (approximately 30-150 days).
The first main focus was identified in the treatment of knee osteoarthritis (KOA). As Lipogems targets patients with moderate to severe knee OA who fail steroid and HA therapies. The entire procedure is performed in a single surgical episode. Through minimal manipulation, without the use of enzymes or other additives, in a closed and aseptic system, there is a progressive reduction in the size of the fat tissue clusters and the elimination of residual oil and blood. The treatment takes place under complete immersion in physiological solution, thus minimising any traumatic action on the cellular products. The product obtained is micro-fragmented, non-expanded adipose tissue for autologous tissue transfer. The absence of gross physical destruction of tissue components, or enzymatic treatment, preserves tissue integrity and makes the tissue ‘minimally manipulated’.The solution involves the use of adipose tissue taken from the patient himself, which is micro-fragmented while keeping the cellular and tissue microarchitecture intact, supporting tissue healing and repair over time (approximately 30-60 days).
A new level of orthopaedics
Mesenchymal (adult stem) cell technology is characterised as a unique opportunity to take orthopaedics to the next level, with broad clinical applications particularly in the various stages of osteoarthritis.
The Lipogems team’s winning intuition was to exploit an area where the regulatory framework, which in the past was particularly permissive, allowed the use of autologous transplants.
In this timeframe, Lipogems has been able to develop its proprietary product and apply it to different areas, while obtaining both recurring revenues and tested clinical data. Today, the regulatory framework is evolving and the time window in which Lipogems has been operating is closing. The team, however, has been ready and is adapting to the new regulations, having started the process of obtaining Pre Market, Approval for the main pathology (OA) and planning the same for the other clinical indications in the pipeline. On 2 June, the Food and Drug Administration gave the fundamental green light by authorising a study on 200 patients in the USA, confirming the track-record of 50,000 treatments already carried out in complete safety and efficacy.
Lipogems aims to create value for the different actors in the process:
- for physicians, the broad clinical utility in the treatment of OA of the knee, shoulder, hip and ankle is emphasised, addressing a large segment of their target customers, especially those (young or old) who are unwilling or unable, due to various pathologies, to undergo invasive surgery.
- For patients, the duration of clinical response and the potential delay of disease progression compared to expensive and invasive surgery are key factors to which Lipogems products provide a solution.
- for partners, the Lipogems solution represents a significant business opportunity in knee OA, particularly given the lack of effective therapies.
Prospects
Lipogems’ business strategy aims to achieve a global reach, starting with the markets of Italy and the United States (which together will generate revenues of around EUR 4.5 million in 2022), and those of Japan (where it has just obtained Class 3A certification) and China. The overall target of these areas is very substantial, as there are more than 100 million cases.
Each of these realities has different barriers to entry, mainly identified in their regulatory systems: market penetration was therefore estimated on the basis of the regulatory bodies’ approval times and the product’s suitability for insurance reimbursement.
Also particularly attractive is Exit’s strategy, which has identified a portfolio of companies that might be interested in Lipogems for various reasons. Several industry players are actively involved in regenerative medicine approaches.
Lipogems is already under the magnifying glass of players that do not have this solution in their portfolio, or otherwise need to enrich their product range by addressing it to the cellular/tissue platform (Ex Integra’s acquisition of Derma Life Sciences in 2017 for $204m, or of Tigenix by Takeda in 2018 for $630m, is an example of a strategic acquisition by medical device companies with the aim of expanding their portfolio of advanced wound care products with regenerative products).
In addition, Lipogems could build partnerships with companies that focus on sports medicine, orthopaedics and wound healing and need to diversify their pipeline with complementary products. In this specific sector, the valorisation of technology is often driven by a competitive process and the extent to which the business/technology would fill a key gap in the partner’s portfolio.
The FDA’s green light is a key step in making the drug reimbursable in the US and therefore Lipogems is a very attractive target for Big Players who currently have hyaluronic acid, cortisone and prosthesis solutions in the pipeline but do not have a regenerative therapy product like Lipogems can be.
Based on the evidence provided by the company (guided by strategic recommendations provided by consultants with recognised expertise such as Back Bay Life Science and Alira health) and the independent research conducted by LIFTT’s team, it is safe to assume an early exit for Lipogems upon reaching reimbursement in the US.
