How is the Artificial Kidney Prize different from previous KidneyX competitions such as Redesign Dialysis?

Redesign Dialysis Phases 1 and 2 were focused on improving the current state of dialysis. The Artificial Kidney Prize aims to accelerate artificial kidney solutions beyond current dialysis methods. For this competition, artificial kidneys may be wearable, implantable, bioengineered, developed as a xenotransplant or chimera organ, or other approaches not yet conceived.

How is the Artificial Kidney Prize different from NIH SBIR, R01, or other similar grant programs?

KidneyX uses prize competitions to engage a broad community of researchers, innovators, and investors to accelerate the pace of kidney care innovation. Prize competitions are, by design, more flexible complements to traditional funding mechanisms like grants and contracts. For example, entrants are awarded prize money based on judging panel evaluation of their solution, without stipulations for how the prize money is used after it is awarded. This flexibility encourages a wider array of new ideas and supports rapid development of high-potential solutions.

Is there a specific method of renal replacement the Artificial Kidney Prize seeks? What approaches or technologies are in scope?

Any technology that advances the goal of making an artificial kidney available for people with kidney diseases are welcome. A primary focus of the competition is to encourage a broad range of solutions to submit. There is no prescribed “ideal” as long as it provides transformational treatment options beyond current dialysis methods, and advances the state of wearable or implantable artificial kidneys.

Can entrants to, or winners of, previous KidneyX competitions participate in the Artificial Kidney Prize?

Previous KidneyX competition entrants and prize winners are encouraged to enter the Artificial Kidney Prize, provided they meet all eligibility criteria noted in the competition rules, terms, and conditions. Participation in previous KidneyX competitions will not inherently advantage or disadvantage any entrant or submission.

Can a faculty member of a university submit a solution without going through the university contract and grant process?

The competition is open to both legal entities and individuals, provided they meet the eligibility requirements as noted in the competition rules, terms, and conditions. Entrants affiliated with a university or other entity are encouraged to consult relevant offices within their respective institutions to ensure compliance with any specific institutional policies.

Are federal employees eligible to participate in the competition?

Any federal employee interested in participating in the competition should consult with their agency’s ethics official to determine whether federal ethics rules will limit or prohibit acceptance of a prize under the competition. Federal standards of ethical conduct may restrict or prohibit federal employees from engaging in certain outside activities. Any federal employee seeking to participate in the competition outside the scope of their employment should consult their agency’s ethics official prior to developing a submission. For more information, please see the eligibility section of the competition rules, terms, and conditions.

Can an entrant submit more than one submission?

Yes, eligible entrants may submit more than one solution to the competition for evaluation.

Can we submit solutions to both the COVID-19 Kidney Care Challenge and the Artificial Kidney Prize?

Submitting a solution to the COVID-19 Kidney Care Challenge does not impact eligibility to submit to the Artificial Kidney Prize; as they are two separate competitions with different submission forms, criteria, and rules. Please consult the COVID-19 Kidney Care Challenge web page for specific information on that challenge.

How do I know if my device/solution is applicable for the competition?

Phase 1 of the Artificial Kidney Prize calls for both component and integrated prototype solutions that advance the functionality, effectiveness, and/or reliability of artificial kidneys. Eligible individuals and teams are encouraged to submit such solutions; please see the submission form, evaluation criteria, and general solution areas of interest for further guidance.

Is the competition restricted to innovations for a wearable or implantable artificial kidney, as opposed to an innovation to improve dialysis?

The Artificial Kidney Prize is calling for solutions that enable and advance the functionality, effectiveness, and/or reliability of artificial kidneys. This competition aims to accelerate artificial kidney solutions beyond current dialysis methods.

Could a solution from other clinical applications be adapted to address kidney functions for the purposes of the competition?

One of the goals of the Artificial Kidney Prize is to engage experts and solutions from a diverse array of disciplines to innovatively address the challenges of developing an artificial kidney. The Phase 1 areas of interest on the Artificial Kidney Prize website indicate a number of these challenges, and solvers from other applicable fields are encouraged to review them as they consider submitting.

What should be submitted as part of Phase 1?

Phase 1 submissions should include demonstrated scientific and technical proofs of concept with detailed development plans. The Phase 1 submission should include a development plan for the next 3-4 years to advance the solution, in line with the goals of the competition. The submission form also asks for a description of the kidney function(s) the component or system could help replicate in the context of artificial kidneys (see 2018 KHI technology roadmap for further guidance).  This description should also include rationale for maturity, safety, and effectiveness claims, such as data from testing (bench or beyond) or other proof of concept evidence. For additional submission requirements, please refer to the submission form.

What type of demonstration data or evidence are you seeking?

It is important that any submission provides a rationale for claims of maturity, effectiveness, and safety. This may be in the form of data from bench, animal, or further testing; or similarly compelling evidence. Each submission must include at least one clear visual, preferably a video file, that demonstrates any functionality described in the submission.

When are proposed solutions expected to start human clinical trials?

The competition aims to accelerate development of artificial kidney solutions toward human clinical trials. Beyond their proposed solution, entrants are asked to provide 3-4-year development plans, as well as identify potential partners or collaborators that would prepare them for successful clinical trial application.

Are solvers required to use the resources provided on the competition website as part of their submission?

Entrants are not required to use any of the resources provided, but they may be helpful in developing submissions. The competition resources page includes information from KidneyX and other organizations about potential solution areas, physiological kidney functions, kidney technology and innovation, patient interaction, and regulatory navigation.

Are there specific functional performance required by the competition (e.g., activities or targets referenced in the Kidney Health Initiative Roadmap)?

Submissions will be assessed based on the official competition evaluation criteria. Resources like the Kidney Health Initiative’s Technology Roadmap for Innovative Approaches to Renal Replacement Therapy may be helpful to solvers in understanding kidney functions and defining or evaluating performance for the current competition phase.

How should submissions be formatted?

As indicated on the competition website, solvers must upload their submission to the competition submission portal by 4:59 p.m. ET on March 24, 2021. Please submit at least one hour before the deadline to ensure your completed submission is received.

Submission uploads should be a maximum of 20 pages; however, additional content may be included in an appendix. The appendix is not guaranteed to receive review by the judging panel but may provide helpful context or clarification. Submission uploads should be submitted as a PDF and formatted with 1-inch margins (2.5 cm), using Times New Roman font with minimum 12-point size for prose, and 10-point font for tables and charts.

Each submission must include at least one clear visual (preferably a video file) of the actual proof of concept that demonstrates functionality. Please ensure the visual or video hyperlink is clearly labeled in your submission documentation; entrants are responsible for ensuring linked content is accessible during the evaluation period.

How many prizes will be awarded for this phase?

Up to $4 million in prize awards will be distributed among up to eight Phase 1 winners, at the discretion of HHS and ASN, informed by the multidisciplinary Phase 1 judging panel’s evaluation. Up to $6 million in prize awards will be distributed among Phase 2 winners, at the discretion of HHS and ASN.

How are prizes distributed to teams representing more than one individual or organization?

Individuals and entities may form and submit a team entry, and each team member must be clearly identified on the team’s submission form for the team to be eligible. Each submission will also have one individual designated as the team lead; any prize money awarded by HHS or ASN will be distributed to the designated team lead for further distribution to team members at the team lead’s discretion.

When will winners be announced?

Phase 1 winners are anticipated to be announced in July 2021. All anticipated milestones for Phases 1 and 2 of the competition are noted on the competition’s timeline.

How will judges determine their scores?

Judging will be based on seven equally weighted criteria. Please see the evaluation criteria page on the competition website for more information. To achieve KidneyX programmatic goals, HHS and ASN may consider the diversity of solutions when selecting winners from the top-scoring submissions recommended by the judging panel.

Will submissions be evaluated both on progress to date as well as future development plans?

As part of their submission, solvers are asked to provide a summary of past progress, current development status (including existing intellectual property), and a detailed development plan for continued iteration, testing, and safety evaluations. Competition judges will consider this information, as well as other submission content, in evaluating each submission against official evaluation criteria. Please see the competition submission form and evaluation criteria for further information.

Will KidneyX recommend specific collaborations or partnerships during or after the current phase of the competition?

The Artificial Kidney Prize team will not suggest or instruct teams to partner. However, we strongly encourage independent collaboration among solvers across phases. (As a reminder, Phase 2 will be open to eligible entrants from Phase 1, as well as new eligible entrants who did not enter the first phase of the competition.) If you are interested in partnering with other interested teams, please sign up for the Artificial Kidney Prize solver community.

Does KidneyX use a TRL-scale?

Beyond the evaluation criteria, KidneyX has not prescribed any specific technical targets or frameworks for the purposes of the competition. Entrants are encouraged to refer to the Kidney Health Initiative’s (KHI) 2018 Technology Roadmap for Innovative Approaches to Renal Replacement Therapy for key function activities, system enablers, supporting activities, and technical design considerations.