SILC - Small Incision Lenticular Cutter

Globally, 17 M people are blind, and 83.5 M have a moderate-to-severe visual impairment (MSVI) due to cataracts, which disproportionately affect individuals in low- and middle-income countries (LMICs). Cataract surgery, involving removing the eye's clouded lens and inserting a synthetic intraocular lens, is a simple, 15-minute procedure that can almost immediately restore an individual's vision. Out of 28M cataract surgeries performed worldwide, 21M cataract surgeries are performed in LMICs annually. However, phacoemulsification (phaco), the expensive, gold standard cataract treatment which involves the use of ultrasonic energy to fragment the cataract into small pieces and aspirate the fragments through a small, < 3 mm incision, is not designed for the treatment of cataracts in LMICs. It requires significant initial capital expense and equipment, high, recurring costs for reusable components, and repeated maintenance. It is also not suitable for treating late-stage cataracts due to the damaging effect of the increased ultrasound power required to fragment ultra-hard, mature cataracts. Moreover, it is not time- or cost-efficient, requiring 10-15 mins and $40-70 per procedure. Thus, underserved patients in LMICs are often relegated to manual small incision cataract surgery (MSICS), where the cataract is manually removed through a 6-7.5 mm incision. MSICS is 1/4th of the cost of phaco, does not require capital equipment or high initial expenditures, is 2.5x more efficient, and can treat mature cataracts. However, its significantly worse post-operative recovery and visual acuity outcomes, due to the large incision, have limited its adoption and hampered care-seeking behavior. At the Aravind Eye Care System (AECS; largest eyecare system in the world; located in India; our key partner; and origin of clinical need), MSICS is used in 70% of cataract procedures (207,000 cases annually). Due to the surgically induced astigmatism, a greater percentage of MSICS patients leave with worse visual outcomes. The high degree of astigmatism induced by MSICS requires visual correction with expensive, cylindrical eyeglasses; however, their rate of adoption is low in MSICS patients. MSICS requires up to 30 days of recovery time, unlike phaco, which only requires up to 3 days. This extended recovery period increases the financial burden of treatment for patients and their caregivers, perpetuating a cycle of delayed care, advanced disease progression, and worse surgical outcomes. Customer discovery through the National Science Foundation I-Corps™ Teams (NSF I-Corps) program, including stakeholder interviews with high volume eye care systems (HVECS) globally, validated a significant clinical and market need for providing gold-standard visual outcomes to all patients at an affordable price point. 

Directly addressing the root cause of the problem (large incision required to remove the entire cataract in MSICS), we developed a proprietary cataract fragmentation technology that can seamlessly integrate into the widely used MSCIS technique to enable gold standard outcomes by manually fragmenting and removing the cataract through a small incision while maintaining a comparable time and cost profile to MSICS. Achieving fragmentation of all grades of cataracts via a low cost, handheld, manual device through a phaco-sized incision will (1) eliminate the need for expensive capital equipment and maintenance, (2) provide gold standard visual acuity outcomes, and rapid recovery for all patients, (3) reduce intraoperative ocular trauma and stress (by eliminating the use of ultrasonic energy), and (4) improve time- and cost-efficiency. The device is designed for safe use through its minimal and tailorable profile, which maintains pressure in the eye during surgery. 

Moreover, the device fits into the existing surgical workflow and training paradigm, and significantly reduces the learning curve for new surgeons by simplifying incision creation. In LMICs, our invention enables health equity and helps eliminate avoidable blindness by drastically improving cataract surgery access and outcomes. Specifically, by reducing the size of the incision required to perform MSICS, our device has the potential to eliminate the need for expensive, astigmatism-correcting glasses and an extended recovery period that affects the most marginalized cataract patients. Through our NSF I-Corps interviews, we discovered that HVECS could improve both clinical and financial outcomes for eye care systems by adopting our innovation and offering a mid-tier surgical package that can capture a growing middle-class segment that desires improved outcomes in comparison to MSICS and is unable to afford phaco at its current price point. By converting non-paying MSICS patients, the hospital can generate additional revenue, reaching self-sufficiency and generating profits that can go into subsidizing free surgeries and expanding hospital infrastructure/services. Our technology is poised to improve access, outcomes significantly, and healthcare economics for the world's most commonly performed surgical procedure. 

India faces the greatest burden of blindness (8.8 M) globally and cataracts are responsible for 24% of all blindness and MSVI in South Asia. We chose to initially focus on the Indian cataract market given our partnerships, the burden of cataracts, and high government, philanthropic, and surgical activity in these countries. Our primary customers and decision-makers consist of executive leadership, directors of quality, directors of outreach, and heads of department for cataract surgery within HVECS (which are private and charitable), our end-users are cataract surgeons performing surgery for low-middle income cataract patients, and our beneficiaries are low-middle income cataract patients and their caregivers. Our customers’ primary needs are to achieve or maintain self-sustainability and expand their services while ensuring quality surgical outcomes, maintaining time- and cost-efficiency, and eliminating needless blindness due to cataracts. Currently, they are underserved in meeting these needs as there is no surgical solution that offers the operational efficiency of MSICS and the outcomes of phaco, resulting in an inability to provide better outcomes for disadvantaged patients and to capture a large and growing middle-income market. For low-income patients, issues with affordability and acceptability of treatment delay care-seeking behavior, causing the development of mature cataracts, leading to blindness and significant functional limitations. In addition, those who do seek treatment in a timely manner often leave with sub-par visual outcomes and face significant financial burden during a prolonged recovery period, perpetuating a vicious cycle of poverty. Discussions with leading HVECS confirmed that our technology has the potential to provide improved surgical outcomes in comparison to phaco and that the technology can be introduced as part of a mid-tier package to capture the growing low-middle income market segment that is both willing to pay and is interested in quality long-term outcomes. In addition to improving outcomes for patients and economics for eye care systems, our invention addresses a major need for primary end-users, junior surgeons, who perform the majority of MSICS procedures, and who require 3,000-5,000 procedures to achieve outcomes comparable to senior surgeons. The steep learning curve in MSICS is associated with creating dimensionally complex and variable 6-7.5 mm incision. We can significantly reduce the learning curve for juniors to achieve optimal outcomes through fewer surgeries (~20 as found in interviews as compared to the current 3000-5000 surgeries), by enabling them to use a simple 3.0 mm incision. 

Our team utilized a spiral innovation model that uses repeated, staged interactions with all key stakeholders to successfully identify an unmet need and bring an appropriate solution to the market. The need was originally identified by our team in 2018 in collaboration with the world’s largest eye care system, AECS, in Southern India, which performs more than 300,000 cataract surgeries annually. AECS, which pioneered the high-volume eye care system model, is a global leader in surgical training and research, and in the manufacture and distribution of ophthalmic products via its manufacturing subsidiary, Aurolab. Since then, our team from the Center for Bioengineering Innovation & Design at Johns Hopkins University has collectively observed more than 125 cataract surgeries and validated that the large incision in MSICS (due to removing the entire cataract in one piece) is the primary contributor to poor patient outcomes through literature reviews and stakeholder interviews. We interviewed over 160 cataract surgeons and leadership in surgical institutes, training centers, and non-profit organizations globally, including AECS, Dr. Shroff's Charity Eye Hospital (SCEH), H.V. Desai Eye Hospital (HV Desai), the Wilmer Eye Institute (WEI), the International Association for Preventable Blindness, and the Seva Foundation. We have raised more than $550,000 in funding to develop technology to improve outcomes and access to cataract surgery. Our solution requirements are tailored to the specific needs of our target customers, end-users, and beneficiaries, and we continue to seek regular input from cataract surgeons of all levels, and executives of HVECS to understand technical challenges within cataract surgery, the current state of the cataract market and the trends in patients’ capability and willingness to pay. For the past few months, we have conducted usability evaluations with surgeons at WEI, and plan to conduct usability testing with surgeons at AECS and SCEH in the upcoming month, enabling us to further engage our end-users in technology design and iteration. We have intentionally developed a device that has the potential to achieve phaco-like outcomes, and be manufactured from low-cost and easily available materials, such that it can fit within the required cost-profile for high-volume eye care centers and its many low-middle income patients. As we begin pilot clinical studies at AECS and other HVECS in India, we will simultaneously work with HVECS to characterize the patient acceptability and impact of surgery with our device.  

Solve’s mission to enable affordable, accessible, and high-quality health systems that serve all is directly aligned with our team’s mission to enable equitable, high-quality cataract treatment for all patients, regardless of socioeconomic status. Solve’s network and support can greatly increase our chances of successfully implementing our technology in emerging markets and ensuring that the benefits of the technology are experienced by the most marginalized patients.  

Given the opportunity to participate in Solve, we seek:   

1. Mentors with experience in the global health space especially in India - our beachhead market, to assist with iterative development of business models to enable outreach to underserved populations. We also seek connections to stakeholders within the Indian government who are leading or working with the Ayushman Bharat government health insurance program implementation which impacts reimbursement for HVECS and consequently our pricing strategy 

1. Mentorship in identifying suitable manufacturers and distributors for our technology and developing impact-oriented contracts that enable our customers to provide our technology to their beneficiaries (cataract patients) at an affordable price.  

1. Legal support as we develop our intellectual property strategy and pursue national filings in India and the U.S. via PCT and mentorship as we navigate non-disclosures while still creating robust partnerships and customer relations.  

1. Access to Solve’s network to unlock new funding opportunities.  

In contrast to existing solutions, our device has been designed for use in LMICs, is less invasive than current techniques, fits within the MSICS workflow (a smaller incision is used, and two additional steps are added), cuts all cataract grades into multiple fragments that can be removed through a phaco-sized incision, allows for dexterity of movement, is a stand-alone device that eliminates the requirement for electricity and maintenance, and has the potential to meet the cost and time constraints of HVECS. The device is composed of inexpensive, accessible materials, and can be manufactured and packaged inexpensively at scale (confirmed by Ingenarious Consulting (IC)); a product development firm specializing in ophthalmology). By enabling non-ultrasonic fragmentation of even mature cataracts through a 3 mm incision in a time- and cost-efficient manner, our device has the potential to reduce the complexity and skill required for surgery, improve the acceptability and accessibility of cataract surgery in LMICs, increase the surgical volume and capacity of eye care systems, and provide improved visual and financial outcomes for more than 21 M patients annually. Stakeholders have expressed strong interest in a procedure with the potential to provide gold standard outcomes while being affordable, eliminating the constraints of phaco equipment, and generating more revenue per MSICS patient. Interviews with key stakeholders from HVECS informed us that our estimated price-point of the device meets cost constraints and that the surgery offered with this technology will likely be priced by HVECS as a median of the two existing procedures and can potentially capture 70-80% of the current MSICS patient population. The procedure would generate additional profit per patient, in comparison to conventional MSICS which is often provided for free or at a subsidized rate, typically at the expense of the hospital or from support by philanthropic sources. Currently, the revenue from phaco surgeries subsidizes free MSICS, and there is no option for the low-middle-income patient population who are willing to pay more for better outcomes but are unable to pay for phaco. With the new surgical offering enabled by our technology, HVCES can capture an entirely new market segment and afford to provide free surgery to low-income patients with superior outcomes to conventional MSICS.  

We plan to initially target markets with a high cataract burden and established cataract surgical systems that have mature training programs and are supported by national programs supporting accessible cataract surgery.  

Clinical validation showing safety and efficacy is critical to creating impact with our solution by driving technology adoption and increasing acceptability of treatment with our technology. In the coming year, we will conduct pilot clinical studies to demonstrate the safety and effectiveness of the procedure compared to phaco and MSICS within HVECS in India, beginning with the Aravind Eye Hospital in Madurai. By Q4 2023 we will initiate large-scale clinical studies to generate the evidence needed to bring more focus to the clinical and social value brought about by surgery with our technology to HVECS and their patients as compared to the current standards of care. 

By 2027 Sight Design Surgical aims to enable this procedure in the top 5 major mission-driven HVECS in India, which cater to 40% - 50% of the total cataract surgical volume in India (6 million surgeries annually) in which 40 – 60% of the population consist of our target demographic. We also aim to sell our cataract surgical system to mission-driven cataract surgical centers in other low- and middle-income countries where we have validated problem-solution fit, such as Nepal, Guatemala, and Benin.  

Target 1: Ensure gold-standard clinical outcomes for patients who would otherwise receive MSICS surgery  

Indicators:  

1. Safe surgery with < 3 % EC loss, without intraoperative complications like iris prolapse or capsular tear for patients with any grade of cataracts
2. UCVA 6/12 or better in at least 90% treatment population and astigmatic error no more than 0.5 D) at 30 days

Target 2: Achieve greater acceptability and equitable outcomes for patients receiving cataract surgery

Indicators:  

1. Reduction in the burden of surgery on the patient and caregiver (faster time to recovery and functional independence after surgery, faster return to work) 
2. Superior visual function – ability to perform tasks requiring attention to finer details 
3. Higher number of individuals seeking surgery for their second eye 
4. Higher number of females taking up the procedure as compared to current offerings 
5. Improvement in care-seeking behavior bringing down the average age of individuals seeking treatment  

Target 3: Improve self-sustainability in HVECS in India   

Indicators:  

1. Reduction in the number of surgeries required for fellows and junior surgeons to achieve optimal outcomes  
2. Increase in the volume of cataract surgery utilizing the new procedure and the associated revenue generated 
3. Allocation of revenue to build surgical or monitoring capacity within communities 

Activities/ Inputs:  

We provide a low-cost handheld cataract fragmentation tool to HVECS to provide gold-standard outcomes to low- and middle-income patients, who would traditionally undergo MSICS surgery, without significantly increasing the procedural cost to the patient or hospital while maintaining the time efficiency of the procedure. 

Outputs:  

• Patients receiving this surgery can return to work quickly due to the short recovery time of 1 week compared to 2-3 weeks in MSICS surgery, and therefore face a significantly reduced financial loss. Due to quality outcomes, patients do not require expensive astigmatism correcting glasses, further reducing the financial burden on the individuals.  
• HVECS providing this surgery to the communities they serve can improve their standing among the community through the quality of outcomes achieved. This procedure helps HVECS enable their mission and provides an additional revenue stream for the long-term sustainability of the healthcare system to provide quality care to underserved communities in their vicinity. 
• Junior surgeons can achieve gold-standard outcomes for their patients using a modified MSICS procedure without significant training (< 20 surgeries) as compared to taking 3-5 years (3000-5000 surgeries) to achieve those outcomes with the current MSICS technique. 

Outcomes:  

HVECS can build their surgical capacity to treat more patients in the community and expand services to include more primary care options such as vision centers in more rural communities.  

Junior surgeons become proficient in the surgery and train other surgeons in other systems and private care facilities. As the procedure gains popularity, it will encourage surgeons to build upon the body of knowledge in training and techniques for more complicated cases.  

Patients can enjoy a higher quality of life with reduced potential for follow-up surgeries and future complications.  

Impacts:  

Short term:  

Due to the low barriers in access and cost of care, we foresee that this technology would (1) enable more equal gender distribution of patients by enabling more women to avail of surgery due to the low barriers to accessibility and affordability of care, (2) patients are more likely to seek treatment earlier and for another eye, (3) enable patients to seek treatment earlier through word-of-mouth of quality outcomes, (4) improve CSRs in the region and country by providing an avenue for HEVCS and other mid-tier hospitals to build capacity and procedural quality. 

Long-term:  

We anticipate an improved reputation of hospitals providing the new procedure, therefore leading to an increase in patients who seek care at the institution. This can bring in more revenue and help expand hospital services by word-of-mouth (which is the prominent mode of dissemination of information). The additional revenue generated would enable institutes to build vision centers (currently a model followed by larger established institutes) that provide primary care and referral services to the communities within the region. Through these initiatives, we anticipate (1) a reduction in the prevalence of mature cataracts within populations served (2) and scaling of the procedure through adoption by the government and small-scale hospitals and private clinics. 

At Sight Design Surgical, we work closely with our partners to develop and test innovative technologies that enable affordable and equitable access to quality surgical outcomes utilizing the spiral innovation model that takes the commercial, technical, clinical, and organizational elements associated with any product or service to successfully create impact.  

Our current technology offering in the cataract space is a proprietary hand-held, low-cost, cataract fragmentation system that utilizes polymer science, mechanical engineering principles, and low-cost manufacturing techniques to meet the need of our customers (HVECS) and beneficiaries (low and low-middle income patients) within LMICs.  

Our device is designed to fit into the current MSICS procedure and function intuitively to reduce the learning curve of residents and junior surgeons (estimate < 20 surgeries to achieve optimal outcomes). Functionally it is designed to capture the cataract in the eye without causing harm to surrounding ocular structures such as the corneal endothelium, iris, and lens capsule and fragment all grades of cataracts of varying sizes and hardness.  

A tested ergonomic design enables compatibility with popular hand postures of cataract surgeons conducting MSICS techniques.  

Our design utilizes available materials for fragmenting elements, actuation system, and device body that can be produced and assembled with well-known manufacturing technologies to enable low-cost manufacturing at scale. The safety profile is designed to be safer than the leading technologies and procedures such as phacoemulsification by avoiding the use of energy sources such as ultrasonic energy that generate heat and pose a risk of damage to ocular structures.  

These compelling factors would allow HVECS to implement the technology within the current training and surgical paradigms with ease and efficiently build surgical capacity to allow more patients to avail themselves of this technology.

The premise of our technology that a smaller incision size in cataract surgery leads to superior visual acuity outcomes and a faster recovery, has been validated through literature review and 100+ stakeholder interviews including interviews with the executive leadership of prominent HVECS in India and around the world. The evolution of cataract surgery itself began from intracapsular extraction (cataract and lens capsule were removed) through a 12mm incision to a 2-3mm incision with phaco and 6-7.5mm incision with MSICS, which was developed as a low-cost alternative to phaco. We specifically validated that a 3mm incision can enable surgical outcomes comparable to phaco. There has been a need to break up the cataract into small pieces that can be removed through a 3mm incision in a way that is safe and time- and cost-efficient, especially in high-volume settings that have tight resource constraints. Throughout our product development process, we repeatedly iterated on our design requirements and technology embodiments based on stakeholder interviews, benchtop testing, and usability testing with cataract surgeons in the U.S. and India. We have iterated on the design of the technology with surgeons at the Wilmer Eye Institute who participated in usability studies in Q4 of 2021 to Q1 of 2022 and showed proof-of-concept that our device can successfully capture and fragment cataract models of varying sizes and hardness' into pieces that can be removed through a 3mm incision. We have iterated on the blueprint of the device such that it can fit within the 3mm incision, and with materials and function that maximizes the use of the available space in the eye while minimizing contact with surrounding ocular structures. In Q2 2022, we will be conducting usability testing at AECS with junior and senior surgeons in our silicone models and ex-vivo human donor eyes to assess the ease of use, efficacy, and overall safety profile of the device. Upon successful completion of usability studies, we will also initiate pilot clinical studies at AECS, who has shown interest in evaluating the technology.

Our team includes individuals spanning multiple cultures, countries, and organizations across the globe mainly within NGOs, private hospital systems, and Johns Hopkins University. The organizations’ advisory team is made up of senior clinicians and leadership from the top HVECS in India, leadership from international NGOs, and experienced engineers from the Applied Physics Lab in the US. We hope to build country-specific advisory committees as the organization expands and before its presence is built within the host country. 

We aim to broaden the participation of women and minorities to create more opportunities for these individuals to develop their technical, entrepreneurial, and leadership skills. We currently include several women residents and corneal fellows-in-training from WEI to contribute to device evaluation and provide feedback on device design and usability. We expect to consult with a diverse group of clinicians (based on experience, ethnicity, culture, and gender), for usability and clinical evaluations within the various cataract surgical systems in India. The organization will consult stakeholders of varying skills in the customer and manufacturing organizations in India to build the training programs and an implementation pathway. 

We are providing cataract surgical institutes with a technology that enables the low-income population they serve to receive gold standard outcomes at an affordable cost to the institute and the patient while enabling the institute to create an additional source of revenue in order to achieve self-sustainability and maintain the quality and cataract surgical volume required to achieve their mission of eliminating needless blindness. Annually, 28 M cataract surgeries are carried out worldwide, with 21 M in LMICs. Given a $15 cost to the hospital for each MSICS surgery, the annual total addressable market is $315 M. Based on our partnerships, the growing trend of cataracts, and high government, philanthropic, and HVECS activity in developing nations we chose to focus primarily on India and Nepal during our NSF I-Corps customer discovery, where we interviewed over 100 key opinion leaders in the field of cataract surgery mainly within India and Nepal. These interviews led to further defining our initial target market (2.8 M annual MSICS procedures in India), leading to an annual serviceable obtainable market (SOM) of $42 M.  

Our initial target segment consists of self-sustaining HVECS in India such as AECS.  These HVECs are self-sustainable, relying mostly on the revenue that they generate from paid surgeries and other services. Leadership within HVECS are constantly faced with the burden of balancing their revenue and costs to be self-sustainable while providing care to the underserved.  

These institutes have the capacity to provide better surgical outcomes for their MSICS patients and wish to offer a mid-tier package that would include a foldable IOL in conjunction with our product. A cataract surgery package with the outcomes of phaco, the time-efficiency of MSICS, and mid-tier pricing offers these eye care systems an opportunity to provide MSICS patients a cost-effective alternative and increase revenue generated per patient, allowing them to become self-sustainable and less reliant on external funding sources while enabling equitable high-quality treatment for their patients. We will partner with local ophthalmic manufacturers and distributors within India such as Aurolab, Care Group, or Appaswamy & Associates, who are experts in low-cost, high-volume production of ophthalmic instruments and consumables, to manufacture and distribute our devices. We anticipate that the device will be classified as a low-risk Class B device, which will require registration with the Indian government and sponsorship from AECS. 

We are currently seeking non-dilutive grant funding for the coming 2 years to support the development, manufacturing, and clinical validation of the product to first sales in India by the end of 2024 - 2025. For this purpose, we are currently applying for additional funding through the NSF and the USAID. Following clinical validation at the Aravind Eye Hospital in Madurai, we will implement the enhanced MSICS technique in Aravind’s training program and simultaneously train key opinion leaders in all 12 hospitals and enable approximately 27,000 enhanced MSICS procedures in the first year.  

Within the first few years, we aim to set up surgical training programs within the top 5 HVECS in India to create an efficient path for implementing the technology. Revenue generated will supplement developing distribution channels and implementation processes within smaller surgical centers and international HVECS with whom we have validated the problem-solution space and who are connected to mission-driven international bodies such as SEVA organization and IAPB (International association for the prevention of blindness). We will also supplement the revenue created with grants from international organizations to enable self-sustainability and capacity building in smaller surgical institutes. 

We have thus far been able to raise more than $550,000 USD through non-dilutive funding from Johns Hopkins University, Abell Foundation, VentureWell, and the NSF. This funding has allowed us to validate the problem-solution fit within India, Nepal, and other LMICs, discover product-market fit within HVECS in India and Nepal, and support initial development and proof-of-concept work for our technology. Funding also supported the development of high-fidelity prototypes that will be used for summative usability studies with surgeons of varying experience levels within our beachhead customer segment in India that consists of HVECS.  

Abell Foundation Fellowship | May 2019 | Tuition fees + stipend of $2500/month for 2 fellows ($120,000) 

VentureWell E-Teams Stage 1 | June 2019 | $5000 

2019 JHU Healthcare Design Competition | May 2019 | $5,000 

2019 JHU Business Plan Competition | May 2019 | $1,000 

VentureWell E-Teams Stage 2 | Dec 2019 | $20,000 

VentureWell BME IDEA International | 2020 | $9,000 

2019 Alliance for Healthier World, Impact Grant | Jan 2020 | $250,000 

Fellowship Support from Center for Bioengineering Innovation & Design | May 2020 - Apr 2021 

Fellowship Support from Center for Bioengineering Innovation & Design| May 2021 - Sep 2021 

I-Corps. Johns Hopkins Technology Ventures | Oct 2020 | $2,880 

I-Corps, National Science Foundation | Dec 2020 | $50,000 

Cohen Translational Engineering Fund | JHTV | $75,000