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Spine


In order to inform near-term investment decisions, our client needed to understand the revenue potential for a spinal implant that was approved in Europe and seeking approval in the US. Our team examined treatment and trends affecting procedure volumes, such as reimbursement and profitability of different procedures, patient demographics and selection, and long-term clinical data. We scrutinized the current and future competitive landscape in this crowded market in the US and Germany, including a detailed review of the clinical data supporting each competitor. Armed with strong market insights from qualitative interviews (with clinicians, industry experts, sales reps, payers, and hospital procurement) and a quantitative survey and detailed secondary research, we constructed a rigorous, scenario-based forecasting tool to model potential sales. By addressing uncertainties with thoughtful scenario modeling, our evaluation provided our client with the business case it needed to make an informed decision on next steps.

Health Advances worked with a private equity firm to evaluate two potential targets in the orthopedics and sports medicine space. The primary target was a biomaterials company, the second, a spine implant manufacturer. Our team evaluated key products from each company and forecasted market potential. Product supply and regulatory threats to the primary Target’s business were assessed, as were threats to the secondary Target’s OEM business. Additionally, potential synergies between these two companies were evaluated. Based on this evaluation, Health Advances made final recommendations to our private equity client on whether or not to pursue these investments.

Health Advances evaluated the US, EU, Japan, and Australia market opportunity for vertebral augmentation to treat compression fractures. In order to evaluate the current market and potential future growth, extensive primary and secondary research was conducted including detailed physicians interviews and surveys and in-depth analysis of procedure trends, reimbursement, and the impact of recent clinical literature and new and emerging products. Trends in the underlying disease states that lead to compression fractures as well as referral patterns were also assessed to develop a market forecast across geographies.

Health Advances evaluated the unmet clinical needs, competitive landscape and market opportunities for a novel bioresorbable spinal fixation device. This study including physician interviews and extensive secondary literature and competitive research to assess the needs of orthopedic and neurosurgeons focusing on the spine with respect to spinal implants for fixation surgery. The research focused specifically on defining key product specifications that experts believed must be met to be utilized in this setting and provided a framework for bench and pre-clinical testing of the novel device.

Health Advances developed the launch strategy for a novel catheter to minimally invasively heat the interior of a lumbar disc to eliminate pain associated with herniated discs. Market segmentation identified segments most likely to adopt the new technology. The project also documented the value of the procedure to payers assuming it could prevent varying percentages of patients from progressing to more expensive procedures. The resulting launch focused on only a few key US geographies and established a high price for the client’s disposables.

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Sports Medicine


As part of a top level comparative effectiveness study, our team assessed the clinical and cost differences between allograft and autograft tissue for ACL reconstruction, as documented in secondary literature published within the last 5 years. Relevant studies on comparative efficacy and cost benefit analyses were analyzed, to understand the associated outcomes and comparative economics of each procedure. 

Identified and quantified clinically relevant population. This involved an interview program of treating physicians, payers and coders to understand clinical segmentation and to identify relevant patient populations. Health Advances identified and quantified relevant patient segment, and determined an economically justifiable pricing strategy based on these target populations.

A large medical device company requested Health Advances’ support to assess the attractiveness of entering the US sports medicine and arthroscopic surgery market. Our team evaluated the current and future market dynamics and created a comprehensive database of companies with product offerings for arthroscopic procedures. The database organized products into key categories and identified the key elements of strong market players. Our resulting deliverable helped the client understand the strategic options for market entry and growth.

As part of an acquisition candidate search, Health Advances evaluated the market dynamics surrounding Platelet concentration systems in plastics and orthopedics surgeries. The study considered use of PRP as a wound healing sealant, soft-tissue growth factor and to augment bone repair.

Health Advances worked with a private equity firm to evaluate two potential targets in the orthopedics and sports medicine space. The primary target was a biomaterials and sports medicine company, the second, a spine implant manufacturer. Our team evaluated key products from each company and forecasted their market potential. Product supply and regulatory threats to the primary Target’s business were assessed, as were threats to secondary Target’s OEM business. Additionally, potential synergies between these two companies were evaluated. Based on this evaluation, Health Advances made final recommendations to our PE client on whether or not to pursue these investments.

Assessed the annual market size, in terms of test volumes, for a device used to diagnose soft tissue musculoskeletal injuries. Health Advances also examined the potential cost-effectiveness of the device in different patient populations and tested the concept of a MDSN strategy, whereby the client would establish provider networks to address patients with musculoskeletal injuries and to boost use of their device.

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Trauma


Assisted client in developing a comprehensive product positioning strategy for growth factor products in trauma, spine and degenerative disc disease populations. Qualitative interviews and quantitative analysis, including conjoint, were used to assess the biologic’s likely penetration into several different medical devices.

Evaluated the orthopedics landscape to determine which segments offered attractive opportunities for our client to build its orthopedics franchise. Health Advances conducted primary and secondary research to assess the market size and growth of the trauma, joint reconstruction, spinal implants, sports surgery, and orthobiomaterials segments to identify potential acquisition targets, and evaluate the strategic fit of these segments with our client. Research was conducted for the US, Europe, and Japan.

Health Advances assisted a research and development company focused on developing bioresorbable polymeric products for the orthopedics market in evaluating the unmet need and market potential for a range of orthopedic bioresorbable products, including internal fixation devices. The Company proceeded with development of its first product and ultimately received FDA approval.

Health Advances assisted a private equity firm in assessing the relative attractiveness of a novel fracture fixation product and procedure. The work involved conducting some background research and then facilitating an onsite discussion with a large group of orthopedic specialists from a variety of sub-specialty areas both before and after a product/procedure demonstration in a cadaver lab. The input from clinicians spanned a broad base of experience and preference so Health Advances’ knowledge of the sector and sub-specialist differences was instrumental in helping to interpret differences in perspectives on the investment opportunity.

Before committing resources to an R&D project, the client wanted to understand the ideal characteristics and sales opportunity for a differentiated conscious sedation monitor. Health Advances interviewed physicians using conscious sedation and secondary research, including CMS surgery center databases, to estimate market potential. Orthopedic procedures were one of the possible indications evaluated for use of the conscious sedation monitor.

As part of a broader strategic planning process for a company interested in growing its mid-sized orthopedics implant and instrument business, Health Advances evaluated the likely demand for disposable instruments for trauma and other orthopedic applications. The trauma sector’s need to have products readily available for unplanned surgeries, differs from the typical business model for most other sectors of the orthopedics/spine market and provided a potential entry point for a disposable instrumentation product line..

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Orthobiologics


Working closely with the senior management team of a publicly-traded microcap biomaterials company, Health Advances developed a corporate strategic plan to exploit their current experience and core competencies, and to assess their organic growth potential and value proposition. To understand the client’s core strengths and identify future industry trends, Health Advances interviewed customers and industry experts to identify potential new opportunities and to understand the relationships between different materials and devices.

Health Advances assisted a research and development company focused on developing bioresorbable polymeric products for the orthopedics market in evaluating the unmet need and market potential for a range of orthopedic bioresorbable products, including internal fixation devices. The company proceeded with development of its first product and ultimately received FDA approval. It is now seeking a sales and marketing partner to assist in commercialization.

Health Advances helped a private, early-stage company better understand the market opportunity for its bioresorbable bone cement a product with unique properties and strong intellectual property positioning. The company wanted to know which indications would provide the best lead candidate versus the best overall market opportunity. Health Advances assessed the market opportunities in cranio-maxillofacial, dental, spinal, and general orthopedic markets.

Health Advances evaluated the orthopedics landscape to determine which segments offered attractive opportunities for our client to build its orthopedics franchise. Health Advances conducted primary and secondary research to assess the market size and growth of each sub-segment within orthopedics, identify potential acquisition targets, and evaluate the strategic fit of these segments with our client. Research was conducted for the US, Europe, and Japan.

Health Advances aided an orthopedics materials company in evaluation of strategic alternatives. The team conducted a preliminary evaluation of the company’s top 5 opportunities to assess their relative technical feasibility and commercial potential. Health Advances also compiled a comprehensive listing of ~300 prospective joint venture partners and prioritized the top 10 companies.

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Regenerative Medicine


Health Advances helped evaluate and prioritize a wide rate of opportunities for growth commercial stage tissue engineering/regenerative medicine company, with the goal of doubling revenue and EBITDA over the next 5 years across a wide variety of indications including sports medicine and orthopedics. Both organic and acquisitive growth opportunities were considered, including opportunities within the current materials area where they had expertise and marketed products, as well as opportunities for growth of existing materials into new medical applications. In addition, we evaluated opportunities in new engineered tissue products, and natural products, where they did not have products, but which could leverage core capabilities of the organization and provide future growth. We considered the pros and cons of vertical integration vs. staying an engineered tissue supplier to OEMs as well. This work looked at opportunities in the US as well as broadly in Europe.

An orthobiologics company engaged Health Advances in preparation for clinical study initiation for a novel, branded biologic amniotic tissue related product. The goals was to develop a reimbursement coding strategy to ensure a distinct HCPCS code, differential pricing, and market protection of Company’s product at launch, in light of similar products expected to be on the market. Our team conducted comprehensive primary research with payers and coding and regulatory experts, as well as secondary research and in-depth analog analysis to elucidate reimbursement strategies for obtaining distinct coding and pricing of similar products targeting similar indications. Armed with detailed market insights, we educated the client on the logistics of obtaining separate HCPCS J codes and identified several strategies that could be employed to ensure differential pricing at launch. 

Worked with the senior team at an established provider of stem cell isolation technology to craft a plan that would propel the Company to profitability and capitalize on the exploding regenerative medicine space. The team used primary and secondary research, conducting several brainstorming sessions with management, and built a robust financial model to illustrate potential paths forward and the financial implications of each. The team settled on hybrid strategy that allowed the Company to maintain its core focus, but still enabled demonstration of the therapeutic value of the underlying technology.

Our team conducted an overview of the regenerative medicine landscape for cell and tissue-based therapies to characterize their growth, future potential therapeutic uses, and needs for new technologies and service providers. The market size and growth over time was projected based on the current clinical development and anticipated future commercialized therapies. Expert interviews and secondary sources informed comprehensive and detailed workflows. Points of unmet need where new technologies or services could offer meaningful improvements to the workflow were also identified and specific acquisition targets to help fill gaps recommended.

To evaluate the potential for cell therapy contract manufacturing and process development services, our team forecasted the commercial opportunity for the cell therapy market and propensity to outsource production over the next ten years. The project included a robust analysis of the clinical development pipeline coupled with industry interviews to understand outsourcing dynamics as cell therapy products transition through clinical phases and into commercialization. Through an in-depth analysis of the competitive landscape, the team quantified revenue potential and made specific recommendations for long-term success for a potential investor.

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Extremities


Working closely with the senior leadership team of a global orthopedics OEM, our team analyzed the total ankle replacement (TAR) market. Our evaluation included identifying the eligible patient population, current TAR penetration, and expected TAR growth into both the ankle fusion and palliative ankle treatment markets for a new generation of TAR products. In addition to evaluating the market, the team analyzed the client’s current product portfolio and R&D pipeline through in-depth interviews and quantitative surveys to help gauge the physician perspective of the client’s products and determine the future market potential.

Health Advances was retained by a large private equity investor to evaluate the commercial potential of a mid-size orthopedic implants manufacturer and to identify strategies for maximizing the target company’s revenue potential. The team executed a rapid, comprehensive assessment of the knee, hip, and extremity implant markets in the US. Research included a large survey, 50 in-depth interviews, and a comprehensive review of clinical literature and other secondary sources. Based on this research, the team built detailed 10-year forecasts for all three markets, modeled potential sales trajectories for the target company, and identified key growth strategies for each business line.  

Health Advances completed a due diligence on a mid-sized orthopedics company for a large diversified chemical company. This project focused on evaluating the company’s extremity implants and orthobiomaterials business units. Specifically, Health Advances spoke with key opinion leaders and launched a 110-physician survey to understand what key criteria drove product choice and how each competitor ranked on those criteria. Health Advances then analyzed the data and provided assessments and recommendations to the client.

A research and development company focused on developing bioresorbable polymeric products for the orthopedics market sought Health Advances’ assistance in helping to evaluating and prioritize the possible applications. The Company had proprietary products and technologies covering bioresorbable orthopedic fixtures, spinal implants and bone cements. The Company wanted to proceed with development of these product lines with the intention of bringing them to a point where developing corporate partnerships would enable the completion of more extensive clinical trials and ultimate commercialization, but it needed top prioritize its R&D efforts and relied on HA to conduct this triaging and prioritization. The final deliverables included an assessment of the current market size, unmet needs, competitive landscape, pricing, & revenue projection for bioresorbable ankle screws in the US.

For a large, EU-based materials and medical device manufacturer, explored the potential for 3D printing of patient-specific devices in the orthopedic, spine, extremities, and trauma markets. The team assessed both the rationale and potential for patient-specific devices regardless of manufacturing technique, and whether 3D printing would enable additional or expanded opportunities. Based on interviews with surgeons and hospital stakeholders, as well as extensive secondary research and research on analogs of existing patient-specific devices, the team was able to identify several promising procedure niches with unmet needs.  Barriers to adoption of patient-specific devices in these sectors were also identified and described. Based on the findings, several different commercial opportunities and business models were proposed to the client to consider whether and where to enter the 3D printing market value chain.

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DME and Rehabilitation


As part of a due diligence, Health Advances was asked to assess the US market for orthotics, softgoods/bracing, and cold therapy going forward and to understand the competitive positioning of the target.  Health Advances also spent time mapping out the provider channel in this industry, outlining the decision making dynamics, and understanding the hospital contracting and purchasing roles and relationships.  An extensive interview program including ortho recon surgeons, sports medicine surgeons, physical therapists, athletic trainers, orthotists, physician assistants, nurses, ortho technicians, sales reps, and practice managers paired with secondary research helped the team achieve these objectives.

A mid-sized device company with a high-cost DME product currently sold as a single-use device was facing increasing cost pressures which led some payers to inquire about possible rental business models. Health Advances was asked to evaluate several alternative business model options, including a rental model, and develop a financial model outlining the expected changes of each business model to revenues, expenses and profitability. Through a comprehensive interview program across multiple internal functional groups, the team mapped out the workflow and costs associated with the current single-use business model. In addition, interviews with clinicians, payers, industry executives, and sales reps were conducted for insight on the competitive landscape and payer dynamics.

Conducted a large diligence project for a private equity firm considering an investment in the prosthetics and orthotics sector. Health Advances’ diligence included an extensive primary research program interviewing dozens of key constituencies in this fragmented and complex space, including sports medicine, joint recon, and spine surgeons, orthotists and prosthetists, physical therapists, athletic trainers, GPOs, office managers, hospital purchasing staff, distributors, sales reps, regulatory lawyers, payers, and more. An assessment of the changing business models was central to the analysis, especially focusing on alternative billing and stocking model options for physician practices.

Assessed the target company’s ability to continue generating sizeable margins and the prospects for increased sales growth. Health Advances interviewed physical therapists and occupational therapists in the hospital, outpatient, long term care and home care settings to learn about the purchase process, vendor choice, trends and any future changes in the market. The team also interviewed chiropractors, podiatrists and exercise physiologists to examine the potential for growth in the markets currently not covered by the company.

Conducted a thorough assessment of the diabetic prescription footwear market on behalf of a private equity firm considering investing in the market. Qualitative and quantitative primary research with primary care physicians, podiatrists, and orthotists/prosthetists were conducted to identify key drivers and barriers of footwear to establish a five-year market forecast. Secondary research and interviews with payers and DME distributors provided key insights on the current and future reimbursement landscape, including the implementation of competitive bidding and other healthcare legislation.

In order to assess the risk of reimbursement rate changes for a durable medical equipment (DME) product, Health Advances rapidly and thoroughly researched the DME reimbursement payment system in the US. The analysis included an overview of rate-setting and rate-changing policies, a historical analysis of DME code payment rates, and analog case studies of rate changes.

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Dental and Maxillofacial


Health Advances was engaged by an investor in dental laboratories to work with the dental labs already acquired to analyze the dental prosthetic market and evaluate positioning and targeting strategies to increase share of the dental prosthetic lab market. Health Advances conducted qualitative interviews with current and former lab customers, as well as a quantitative survey involving conjoint exercises for 4 different dental crown products.  The analysis of nearly 900 national responses resulted in key insights into the drivers and barriers involved in switching and adopting dental laboratories, as well as the importance of lab proximity, quality, price, service, and support options in dentists’ selection of dental labs. Health Advances developed recommendations for the client for increasing share in the local market as well as expanding on a national level for long-term success. 

Health Advances conducted a thorough review of biomaterials in two specific markets, dental and neurosurgical. Evaluating recent product use trends, current and emerging pipelines, and physician and purchasing manager feedback, Health Advances built a detailed perspective of these biomaterials applications and markets.

A private early stage company was seeking to better understand the market opportunity for its bioresorbable bone cement. The cement had unique properties and a strong intellectual property position. The major question was which indications would provide the best lead candidate vs. the best overall market opportunity. The assessment covered market sizing in cranio-maxillofacial, dental, spinal, and general orthopedic markets.

A leading device company asked Health Advances to assist in the due diligence for a proposed in-licensing deal related to a biologic product used in periodontal applications. The analysis focused on secondary research, interviews with key members of the acquirer’s due diligence team, as well as conducting confirmatory physician interviews.

As part of a rapid due diligence to assess the purchase of a product line (drug with local delivery category) used in treatment of periodontal disease, the team evaluated a specific competitive technology (laser category) in development. The project consisted of a primary interview program with practicing Periodontists as well as Periodontists active in clinical trials for the relevant technologies. These interviews, as well as an earlier secondary investigation into the clinical evidence supporting the competitive technology, allowed the team to assess the competitive threat of the competing technology and the likelihood of adoption among both Periodontists (primary focus of research) and Dentists (less direct focus of research).

A large medical device company was developing a biomaterial for oral surgery applications. Health Advances was tasked with justifying the premium price of the new product from the perspective of the Oral and Maxillofacial surgeon. We analyzed the economics of the oral surgeon’s office practice including the fees, costs, and frequency of typical procedures. Health Advances created an argument that demonstrated the value of the novel product through time savings to the surgeon, allowing for more profitable procedures to be performed. Health Advances also identified several upside opportunities which could further increase the value of the biomaterial to the surgeon. Health Advances created a model demonstrating these advantages as well as a simple worksheet for use by sales representatives in the field.

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Pain Management


Conducted a study to determine the market opportunity for a novel, post-operative pain (POP) treatment in the UK, Germany, France, Spain, Italy, Australia, New Zealand and Canada. Health Advances conducted a survey to assess the current treatment landscape, associated costs, and likely impact of using this novel, local, implantable alternative for POP management. The team developed a five-year revenue projection for multiple indications including spinal fusion, bunionectomy, hip replacement, knee replacement, shoulder replacement and long bone fracture repair.

Helped a biotech company with a newly launched opioid to identify directions and opportunities to further develop pain market presence, including evaluating how best to position and penetrate into the orthopedic surgeon market and with other clinical specialists. The team conducted a comprehensive review of the market and identified growth areas by both class and mechanism, including a list of pain licensing candidates.

Evaluated the commercial prospects of an advanced drug delivery systems for post-surgical pain relief and surgical site care. The team forecasted the use of continuous peripheral nerve blocks by anesthesiologists and the use of wound infusion devices placed by surgeons. Key procedure criteria leading to use of these techniques and/or competitive options were articulated and used as screening criteria to estimate market potential for a long list of inpatient and outpatient procedures. Physician interviews, regional anesthesia training trends, and facility economics were evaluated to qualitatively project the product’s potential penetration of this potential.

The client was creating an NSAID formulation to be used for inflammatory conditions. Health Advances identified rheumatoid arthritis, osteoarthritis, chronic low back pain and acute musculoskeletal pain as the lead indications and estimated the market size for a transdermal NSAID product based on in-depth physician interviews and an approximate price point.

Assessed the annual market size, in terms of test volumes, for a device used to diagnose soft tissue musculoskeletal injuries. Health Advances also examined the potential cost-effectiveness of the device in different patient populations and tested the concept of a MDSN strategy, whereby the client would establish provider networks to address patients with musculoskeletal injuries and to boost use of their device. This diagnostic was initially being used to evaluate the source of cervical and lumbar pain, both where the problem was and also as a way to identify malingerers who really did not have a problem (a concern with prolonged workers’ compensation cases).

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Digital Health and Orthopedics


The team worked with medical device company to prioritize applications and build a commercial strategy for an implantable sensor device designed for post-op monitoring of total joint replacement patients. The team assessed unmet needs, complication rates, alternative technologies, reimbursement dynamics, and other factors to help the client prioritize applications and build a strategy. Analysis was based in in-depth research with surgeons, pain management experts, physical therapists, physiatrists, payers, and purchasing directors. The team created a patient-based revenue forecast and outlined a long-term R&D roadmap for the solution.

For a small orthopedic company, Health Advances conducted a literature review of the current economic and clinical data supporting the use of said company’s novel soft-tissue balancing technology. The company’s prospective clinical trials were also evaluated and additional endpoints were suggested to ensure a meaningful cost-benefit analysis of the soft-tissue balancing technology could be performed within the 90-day window, and other timeframes between 90 days and 2 years. Furthermore, Health Advances determined the feasibility of a larger cost-effectiveness analysis and evaluated additional sources of data that could supplement what information the client had internally, including registry data, claims data, interviews, and clinical trial data.

A medical device company with a marketed product used in total knee replacement surgery was developing a wearable sensor and monitoring system to grow its business and expand outside of the OR. The client engaged Health Advances to evaluate the opportunity for this Digital Health product and inform upcoming product development efforts. We conducted a rigorous assessment of the Digital Health landscape in Orthopedics, informed by a mixture of competitive landscape research and interviews with knee replacement surgeons, physical therapists, practice and hospital administrators, payers, and Digital Health/Orthopedics OEM executives. In addition to collecting feedback, we also profiled six other companies in the Digital Health space to illustrate the potential value of the client’s product as well as commercialization lessons learned. The results of the research, presented over multiple meetings with the management team, allowed the client to recalibrate and refocus its product design efforts, as well as pursue targeted partnership opportunities for greater commercial success.

Health Advances helped a leading multinational medical device company identify opportunities to leverage Health IT in order to deliver greater value to customers and accelerate growth of the company. The team conducted a thorough assessment of medtech digital health activity to date, identified a wide range of potential digital health strategies for medtech companies, and developed several promising digital health opportunities specific to the client’s current business and market position.

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